Bio-Reg Associates, Inc. - Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
Biotech Consultant LLC - 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.
21 CFR Consulting - Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries.
21 CFR Part 11 Compliance Resource - A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
21 CFR Part 11: Worldwide Pharma Solutions Inc. "Compliance Specialists" - WWPSI provides 21 CFR Part 11 and chromatography validation services to pharmaceutical laboratories throughout USA, Puerto Rico, and the EU. Specialists ensure compliance for computer systems validation and laboratory systems automation.
Chestnut Solutions Inc. - 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.
Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
Coding Compliance Solutions - 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.
Compliant Projects Ltd. - Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.
Critical Path Consultants, LLC - Provides customized consulting services including quality system, process validation, or compliance-related (ISO, FDA, CE mark) issues, as well as R&D, design, and product testing.
Doctor Device Consultant - Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices.
Drumbeat Dimensions Inc. - Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
The Due Diligence Group - Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry.
Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
Entrinsik - 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.
GMG BioBusiness - UK based product development service company providing strategic support and regulatory affairs resources.
GMP Experts - Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
GMP Online Consultancy - European-based, Good Manufacturing Practice (GMP) Online Consultancy
Harpaz Consulting Services - Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
Hippa Custom - HIPAA compliance, training, and assessment.
The Horizon Phoenix Group Quality System Consultants - Consulting company providing assistance to companies developing ISO9001 and CE systems. Its clients range from a small niche market manufacturer to the United Nations.
International GCP Auditor - GCP and systems Auditor, Pharma Companies and CRO clients, numerous, since 1992. Clinical trial study site, sponsor and CRO audits, phase II to IV
ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
Kamm & Associates - Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm & 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.
Lachman Consultant Services - 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 R&D and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries
Leonard T. Flynn - 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.
Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
Liquent, Inc. - Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
Lubin Consulting Inc. - Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs.
Marion Weinreb and Associates, Inc. - Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
MDI Consultants, Inc. - FDA, IVDD, CE mark, HACCP, ISO9000, and GMP compliance consulting company for the medical device industry.
Medical Device Consultants, Inc. (MDCI) - provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements.
Medical Device Technology Consultants - Cambridge 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.
Medical Devices Consulting - Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
Medius AG - Drug Regulatory Affairs and Development - Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
Milestone Biomedical Associates - A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices.
Online HIPAA training - Online training for HIPAA compliance for insurance professionals.
Pensa Technology Solutions Inc. - 21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems.
Perkins and Perkins - FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
QCT Solutions, LLC - Specialities include cGMP systems, for cause audits, and PAI preparation.
QRC Associates - QRC Associates provides management with cGMP and QSR advice.
Quality First International Ltd. - 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
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.
RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries.
Regulatory and Validation Provider - Validation Associates, Inc. (VAI) provides regulatory compliance consulting services including 21 CFR Part 11 gap assessments, software and computer system validation, process validation, and system and vendors audits to life sciences companies through its network of consultants and industry experts
SDCS - Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
Smith and Associates - A consulting firm specializing in regulatory affairs for medical device manufacturing.
Tarius Interactive - Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge management system based on XML architecture.
Thomas E. Colonna Ph.D./J.D. & Associates - 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.
Validation and cGMP Compliance - Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
Validation Masters, Inc. - Company serving the pharmaceutical manufacturing and clinical research industries.
Validation Technologies, Inc. - Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
Westerwald-Institute - German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English.
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