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ARX - Digital Signature Solutions - http://www.arx.com
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. |
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21 CFR Part 11 Compliance Resource - http://www.21cfrpart11.com
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. |
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Tarius A/S - http://www.tarius.com/
Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. |
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Ceutical Labs - http://www.ceuticallabs.com
Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product development, project management, validation, quality, regulatory affairs, IT, sales, and marketing. |
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BuzzeoPDMA, Inc. - http://www.buzzeopdma.com
PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory and System Auditing Services and Validation, State Requirements and Licensing, DEA Regulatory and Operational Solutions, Training, Security Vulnerability Assessment (SVA). |
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21 CFR Part 11 Compliant Solutions - http://www.part11solutions.com
Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. |
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Medical Device Consultants, Inc. (MDCI) - http://www.mdci.com
provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements. |
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Emergo Group - http://www.emergogroup.com
Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. |
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ComplianceFDA, Inc. - http://www.complianceFDA.com/
FDA warning letter and CFR categorization and search database. |
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Clinical Device Group Inc. - http://www.clinicaldevice.com
Clinical Device Group offers full CRO services for medical devices manufacturers. |
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ERA Consulting Group - http://www.eraconsulting.com
Specialist services for pharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe and the United States. |
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Entrinsik - http://www.entrinsik.com
Their employee development solutions provide for compliance management and learning management; our Gxp compliance Edition is "validation ready", ideal for GxP compliance training requirements in the pharmaceutical or medical device industries. |
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Octagon Research Solutions, Inc. - http://www.octagonresearch.com
Offers a suite of services that span the entire clinical research and development lifecycle. |
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HIPAA Training & Compliance Consulting - http://www.training-hipaa.net
Provides HIPAA training, compliance kits, manuals, disaster recovery and business continuity templates and compliance consulting services. |
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PharmaReady - http://www.pharmaready.com/
PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. |
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European Authorized Representative - http://www.obelis.net/
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. |
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UK Medical Device Consultancy - http://www.medicaldeviceconsultancy.co.uk
Provides medical device companies with business development services from regulatory affairs, quality systems to strategic reviews, marketing advice, strategic market research, product management from concept to market, business planning, distribution and partner search. |
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Jouhou Koukai Services - http://www.jouhoukoukai.com
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. |
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Regulatory Affairs Syndicator - http://regulatory.schwoebel.net
This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration. |
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Reg123.com - http://www.reg123.com
Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process. |
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Kemic Bioresearch - http://www.kemic.com
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). |
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Wainwright Associates - http://wainwrightassociates.co.uk
UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry. |
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Doctor Device Consultant - http://www.doctordevice.com/
Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices. |
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ASG Inc. - http://www.asg-inc.com
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. |
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Qserve Group - http://www.qservegroup.com/
Qserve® Group B.V provides CE Marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services. |
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Kinesis Pharma BV - http://www.kinesis-pharma.com/index2.htm
Consultants in drug development. Located in the Netherlands. |
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Applied Regulatory Consulting Ltd - experience applied for pharmaceuticals - http://www.appliedregulatory.com
Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. |
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PinneyAssociates - http://www.pinneyassociates.com/
Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy. |
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Abrimed - http://abrimed.com
Regulatory affairs consultants for ISO, GMP, and FDA compliance |
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Masy Systems - http://www.masy.com/
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies. |
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FDA Compliance Solutions - http://www.fdacompliancesolutions.com
FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting. |
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Biologics Consulting Group - http://www.biologicsconsulting.com
FDA regulatory experience and provide regulatory application support, "mock" FDA inspections, vendor and clinical trial site audits, statistical services, clinical trial design/review, and preparation of responses to FDA compliance actions. |
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Validation in Partnership Ltd - http://www.vipltd.co.uk
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. |
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VTS Consultants, Inc. - http://www.vtsconsultants.com
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. |
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Cabridge Regulatory Services - http://www.cambreg.co.uk
Specialists in the field of pharmaceutical regulatory affairs. |
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Tecno-med Ingenieros - http://www.tecno-med.es/
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. |
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Lachman Consultant Services - http://www.lachmanconsultants.com
Provides expert technical consultation in the areas of FDA Related Activities, Quality Control / Quality Assurance, Validation / Qualification, Stability / Expiration Dating, Research and Development of Pharmaceutical Dosage Forms, New Facilities Construction for research and development and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries |
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QRC Associates - http://www.qrcassociates.com
QRC Associates provides management with cGMP and QSR advice. |
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FDA Advisors with scientific and technical expertise - http://www.phoenixrising.com
Regulatory affairs consultants based in the Washington DC metro area with the industry and FDA expertise to aid small to large pharmaceutical and medical device companies. |
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UNICUS REGULATORY SERVICES - http://www.unicus.co.uk/
Unicus regulatory services is a European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance. |
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MAPCIS Validated Labeling Solutions - http://www.mapcis.com
FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance. |
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FDALive.com - http://www.fdalive.com/
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available. |
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21 CFR Consulting - http://www.21cfrconsulting.com/
Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries. |
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PRISYM ID Compliant Barcode & Labeling - http://www.prisymidinc.com
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. |
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Aitheras, LLC. - http://www.aitheras.com/
Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. |
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AQA - http://www.aqapress.com
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. |
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Medical Devices Consulting - http://www.qsrhelp.com
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. |
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Quality First International Ltd. - http://www.qualityfirstint.com
QFI is a European based consultancy providing CE marking services, EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity Assessment support and compliance audits |
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Innovative Consultancy Services - http://www.pharmaceutical-consultancy.com
We are an Indian pharmaceutical consultant company established in the year 1998 and providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services. |
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Sigma Biomedical - http://www.sigmabiomedical.com
Sigma Biomedical supports biomedical research and medical device development by providing custom solutions. |
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Chestnut Solutions Inc. - http://chestnutsolutions.com/
Offers global regulatory strategies, document management, electronic submissions and CTD filings to pharmaceutical and biotech companies and contract research organizations in Canada, Europe and the US. |
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Quality Systems Laboratories - http://www.qslabs.com
Provides compliance process management and eLearning products and services. |
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GMP Online Consultancy - http://www.gmp-online-consultancy.com
European-based, Good Manufacturing Practice (GMP) Online Consultancy |
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GCP Training Online - http://www.gcptraining.org.uk
GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. |
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TDC Software - http://www.tdc.fr/en/products/tdc_fmea.php
TDC Software is an engineering software suite covering risk management. |
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Perseus Partners - http://www.perseus.be
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. |
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Reg-info.com - http://www.reg-info.com/
A collection of links to websites with information relating to regulatory affairs and the development of medicines. |
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Validation Systems, Inc. - http://www.validationsystems.com
We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing. |
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Pensa Technology Solutions Inc. - http://www.gmps.com/
21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. |
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Coastal Consulting Group, Ltd. - http://www.coastalcg.com
Medical device regulatory affairs, clinical studies, quality systems, and documentation services. |
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Coda Corp. USA - http://www.codacorpusa.com/
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. |
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Global Regulatory - http://www.globalregulatory.com/
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. |
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ADN - http://www.adneurope.com
Compliance for electronic record management for FDA regulated companies. |
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European consulting for the healthcare industry - http://www.qarad.com
Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. |
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HDM Corp. - http://www.hdmcorp.com
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers. |
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Comply - http://www.comply.co.il
Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, stability studies, and trends analysis. |
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Perkins and Perkins - http://www.perkinsandperkins.net
FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation. |
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SDCS - http://devicecompliance.com/
Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. |
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Validation Technologies, Inc. - http://www.validation.org/
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. |
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MedPharmTec Services - http://www.medpharmtec.de
German consultant for the pharmaceutical industry. |
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Pharmaceutical Regulatory Affairs Italy - Di Renzo - http://www.direnzo.biz
Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. |
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Horizon Phoenix Group - http://www.horizonphoenix.biz
Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses. |
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Quality Medical Regulations Services - http://www.qmrs.com/
Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. |
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Enterprise Risk and Compliance Management - http://azilon.com
Provides compliance solutions for Healthcare and Financial Sector. |
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QuadraMed - http://www.quadramed.org.uk/
A pharmaceutical regulatory company with European affiliated offices specializing in marketing authorizations, European clinical trials, mutual recognition procedures, and orphan drug designations. |
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Drumbeat Dimensions Inc. - http://www.drumkey.com
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. |
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eHIPAA Training - http://www.ehipaatraining.com
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. |
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Di Renzo Regulatory Affairs - http://www.pharmaflash.com
Di Renzo Regulatory Affairs is a pharmaceutical consultant aiding companies that need to register products (from medicines/dietary supplements and medical devices to cosmetics) at the AIFA and the Italian Ministry of Health. |
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ARx Pharmaceutical Regulatory Consultancy LLC - http://www.arxpharma.com/
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. |
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Q-NET LLC - http://www.ce-authorizedrepresentative.eu
EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments. |
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PAT toolkit - http://www.pattoolkit.com
Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative. |
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Medical device consultants - http://www.fdamaze.com
Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training |
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TRAC Services - http://www.tracservices.co.uk/
A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. |
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Regulatory Affairs, North America LLC - http://www.ranallc.com
Regulatory affairs consultancy headquartered in North Carolina. |
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Regulatory Affairs Associates LLC - http://www.regaffairs.net
RAA (regulatory affairs consultancy) |
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The Arazy Group - http://www.arazygroup.com
Medical Device RA and Quality System Consultants |
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HIPAAdirect - http://www.hipaadirect.com/
A directory of HIPAA links |
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Ehrreich Consulting, Inc. - http://www.regsolutions.com
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. |
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CMAC Consultancy - http://www.cmacusa.com
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training and implementation, project administration and commissioning, as well as, IT services/operation management. |
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Alphapharma Consulting - http://www.alphapharma.com/aboutus.html
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. |
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Accurate FDA Consultants - http://www.accuratefdaconsulting.com
FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. |
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Computer System Validation - http://www.ComputerSystemValidation.com
Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. |
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Compliance Control Ltd. - http://www.compliance-control.com
Provide software products and consultancy expertise to help companies achieve compliant and validated systems. |
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Kamm & Associates - http://www.fda-consultant.com
Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm and Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training. |
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nFocus Technologies ERP for Life Sciences - http://www.nfocustechnologies.com/industry-solutions/life-sciences-erp-solution.asp
nFocus Technologies has developed a portfolio of software solutions to meet the requirements of this highly regulated industry. |
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The Tamarack Group - http://www.thetamarackgroup.net
Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide regulatory approvals and compliance services (GMP, QSR) for product development and manufacturers of medical products (US FDA, EU, Canada). |
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Pharmalink Consulting - http://www.pharmalinkconsulting.co.uk
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC |
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Atubra Inc. - http://atubra.com
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. |
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Sagaem - http://www.sagaem.it
Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy. |
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Qware Riskmanager - http://www.risk-online.com
A management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971. |
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DRW Research & Information Services, LLC - http://www.drw-research.com
Provides regulatory affairs research and information for the healthcare industry. |
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ATC Corp. - American Technical Consultants - http://www.atccorp.net/
Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. |
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RegulatoryPro.com - http://www.regulatorypro.com
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. |
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Delphi Consulting - http://www.delphiconsulting.com
Delphi Consulting Group provides US FDA consulting services for medical devices. |
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Harpaz Consulting Services - http://www.harpazconsulting.com/
Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. |
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OMSBAR - http://www.omsbar.com/
OMSBAR provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management, verification and validation, and maintains a core staff of experienced medical device personnel. |
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Pharmaceutical Development Group - http://www.pharmdevgroup.com
Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and cGMP inspections. |
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Seraphim Life Sciences Consulting LLC - http://www.seraphimlifesciences.com/
Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. |
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Marion Weinreb and Associates, Inc. - http://gmpsrus.com
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. |
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SMB Validation and Compliance Services Group - http://www.smbvalidation.com/
SMB Group is designed to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations. |
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R. A. Q .A. Associates - http://www.raqaassociates.com
R.A.Q.A. Associates provides FDA and ISO related consulting services to medical device and pharmaceutical companies. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory systems or improving existing systems. |
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Validation Online Net - http://www.validation-online.net
Generic downloadable documents that are cGMP compliant. |
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BesTech regulatory consulting - http://www.bestechconsulting.biz
BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. Provide solutions for regulatory compliance, product safety, litigation support and design and development of medical devices. |
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IDEC Validation Ltd - http://www.idecvalidation.com/
Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has field knowledge in the implementation of compliance solutions. |
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Allegheny Associates - Regulatory and Clinical Affairs Consulting - http://www.schwoebel.net
Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy. |
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Draco Associates Ltd. - http://www.dracoassociates.com
Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. |
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Samarind Regulatory Management Software - http://www.samarindrms.co.uk
Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. |
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Regulatory Bureau "Cratia" - http://www.bureaucracy.com.ua
Consulting and active assistance in registration (regulatory affairs) and clinical trials of medicinal products, API's, supplements, and medical devices in CIS countries (Ukraine, Russian Federation, Kazakhstan, Moldova, Byelorussia). |
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GCP Solutions - http://mysite.verizon.net/sisbill1/gcp.htm
GCP Solutions provides good clinical practice consulting services. |
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Quality Vectors - http://www.quality-vectors.com
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. |
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QSite - http://www.qsitemed.com
Qsite is a consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance. |
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Leonard Steinborn Consulting, LLC - http://www.leonardsteinbornconsulting.com
Provide FDA related regulatory submission, training, auditing and consulting services. |
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RS Consultant Services - http://www.rsconsultantservices.com/
Offering consulting services to Canada and USA in dealing with regulations for medical devices and pharmaceuticals. |
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Gamp Forum - http://www.gampforum.com
Bio-Pharma professionals forum. |
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European Pharmaceutical Consultants - http://www.pharma-eu.com
European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. |
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PH PharmAnalysis GmbH - http://www.pharmanalysis.de
Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. |
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CIEX, Incorporated - http://www.ciexinc.com
CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. |
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CL Tech Inc. - http://www.qualityleader.com
Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations. |
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Lorentzson FDA Consulting Services - http://www.clorentzson.com/
Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms. |
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Carexa Inc. Regulatory Consultants - http://www.carexa.com
Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs. |
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Compliance Associates - http://www.complianceassociates.ca
Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. |
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Medius AG - Drug Regulatory Affairs and Development - http://www.medius-ag.ch
Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics. |
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GMP Experts - http://www.gmpexperts.com/
Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies. |
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Brandt Research Consulting LLC - http://www.brandtconsulting.us
Providing a wide range of consulting services in GCP, GLP and GMP compliance. |
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Biotech Consultant LLC - http://www.biotech-consultant.com
Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products. |
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ISOComp, Inc. - http://www.isocomp.com/
ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. |
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Lewis CMC Consulting - http://www.lewiscmc.com
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. |
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RegIntel Ltd. - http://www.regintel.com
Provides international regulatory solutions to the pharmaceutical and biologics industries. |
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The Matthews Consultancy - http://tmconsultancy.com
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. |
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Coding Compliance Solutions - http://codingcompliance.com
Consulting firms specializing in supporting hospitals, physicians and attorneys address complex coding issues. Major emphasis on working with counsel in support of fraud and abuse allegations from third-party payers. |
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Leonard T. Flynn - http://www.drflynnconsulting.com
An independent regulatory and scientific consultant who provides assistance to pharmaceutical, health product and chemical manufacturers for them to meet the requirements of government agencies. |
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Thomas E. Colonna Ph.D./J.D. & Associates - http://www.tcolonna.com
Provides consulting services in the scientific and regulatory aspects of a wide range of medical devices with particular expertise in the areas of in vitro diagnostics and biotechnology-based products. |
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Regulatory Affairs Consulting - http://www.newdrugapprovals.com
Regulatory affairs consulting services to the pharmaceutical and related industries. |
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Spherelink FDA Consulting - http://spherelink.com
Spherelink provides FDA consulting and international trade consulting between Asia and the United States. |
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Creative Consultants India - http://www.creativeconsultantsindia.com
India-based agency engaged in preparation of registration dossiers for export of drug formulations. We also prepare clinical trial reports, training manuals, drug master files, SOPs, and validation reports. |
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Smith and Associates - http://www.fdaconsultants.com/
A consulting firm specializing in regulatory affairs for medical device manufacturing. |
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Acerna Inc. - http://www.acerna.ca
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. |
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Quality Solutions - http://www.validationprofessionals.com
Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. |
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THINQ Compliance Ltd. - http://www.thinqcompliance.com/
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. |
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Bryn Mawr Partners - http://www.brynmawrpartners.com
Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems. |
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Perfect Consultants - http://www.perfect-consultants.com
Perfect Consultants is an association of pharmaceutical experts providing regulatory consultation to the pharmaceutical industries in the development of dossiers, Drug Master Files (DMFs), and Common Technical Documents (CTDs). |
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GCP Auditing Services - http://www.gcp-auditing.com
An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. |
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GCP cursus - http://www.gcpcursus.nl
Cursussen Good Clinical Practice |
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Exalon - http://www.exalon.com
Specialized on eCTD submissions. |
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Barnhill & Associates, Inc. - Pharmaceutical Consultants - http://barnhillassociates.net
A specialty based consulting firm specializing in a range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena. |
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Tumont Limited - http://www.tumont.co.uk
Specializes in providing cGxP equipment and software validation support to pharmaceutical laboratories in UK. They can provide plans, protocols, reports, SOPs, inventories and training on a fixed cost basis. |
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GLP Quality Consulting - http://www.glpqualityconsulting.com
Good Laboratory Practice (GLP) consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. |
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MarcM Consulting Canada - http://www.marcmconsulting.ca
Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical research/trials, bioequivalence studies, and DMF preparations. Regulatory and business development services offered in English, Portuguese, and Spanish. |
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Medical Device Technology Consultants - Cambridge UK - http://www.mdtconsultants.co.uk/
MDTc is an independent consultancy to the medical devices industry. Based near Cambridge, England, MDTc helps bring products to market and comply with regulatory requirements. |
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Validation and cGMP Compliance - http://www.cqionline.com/
Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. |
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Arvin Shroff Associates LLC - http://www.arvinshroff.com
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. |
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Regulatory Pharma - http://www.regulatorypharma.com/
Regulatory Pharma provides regulatory affairs consultancy services (registration and reimbursement of medicinal products (Rx, OTC, plant origin), medical devices, food supplements, and cosmetics) in Poland and Romania. |
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International Regulatory and Business Consultant - http://irb-c.com
Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries |
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Lyons Baxley Regulatory Compliance Group - http://www.lyonsbaxley.com
Regulatory compliance consultants servicing the pharmaceutical, dietary supplement, foods, and cosmetics industries. |
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MDI Consultants - http://www.mdiconsultants.com
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. |
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Estrin Consulting Group, Inc. - http://yourfdaconsultant.com/
ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Founder and President: Norman F. Estrin, Ph.D. Regulatory Affairs Certified. |
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New World Regulatory Solutions/SOOP International - http://soop.us
Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. |
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Kennedy Medical Writing Service - http://www.kennedywritingservice.com
Medical writing and proofreading company. |
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Liquent, Inc. - http://www.liquent.com
Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. |
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Veirup Consult - http://www.veirupconsult.dk
Danish regulatory affairs consultancy |