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Estrin Consulting Group Inc.
9109 Copenhaver Dr.
Potomac, MD 20854
Tel: 301/279-2899
Fax: 301/294-0126
E-mail: estrin@yourfdaconsultant.com
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Description:
Provides services relating to FDA regulatory issues to medical device manufacturers, including FDA submissions, strategy development, manufacturing, quality systems and compliance, preparation for FDA meetings, education and training, and expert witness, and acts as an agent/official correspondent for foreign companies. The firm was founded by a former HIMA (AdvaMed) vice president of science and technology who is regulatory affairs certified and has created and edited books on regulation of medical devices and cosmetics.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (73 companies)
