Creative Consultants India
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.
Delphi Consulting
Delphi Consulting Group provides US FDA consulting services for medical devices.
Di Renzo Regulatory Affairs
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.
Directory of information for pharmaceutical regulatory affairs
reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs
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.
Ehrreich Consulting, Inc.
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
Enterprise Risk and Compliance Management
Provides compliance solutions for Healthcare and Financial Sector.
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.
ERA Consulting Group
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.
Estrin Consulting Group, Inc.
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.
European Authorized Representative
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
FDA Advisors with scientific and technical expertise
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.
FDA Compliance Solutions
FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting.
FDACompliance.Net
Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
FDALive.com
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
FDC Services
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
Global Regulatory
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
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.
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