Leading the Way in Pharmaceutical and Device Consulting

Clinical & Medical Consulting

Epstein Associates will guide you through the intensive processes concerning clinical research, medical device and technology, and regulatory affairs.

Business Development

Epstein Associates assists with the assessment of new therapeutic areas/opportunities, evaluation of partnership opportunities, evaluation of product opportunities, and the evaluation of other business development opportunities.



Epstein Associates assists with Post Marketing Safety Surveillance, regulatory consulting, protocol writing, CRF creation, and research Clinical Development study design.

Regulatory Affairs


Epstein Associates will arrange a mock FDA panel meeting.  Our services include the development of a comprehensive panel strategy for the sponsor including organizing a slide presentation, streamlining Q & A and creating a Post Panel Action Report.


Legal Consulting, Pharmaceutical Patent Consulting, Patent Infringement and Device Infringement

legal medical consulting

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News & Announcements

Biosimilars: The Need, The Challenge, The Future: The FDA Perspective

This article summarizes the brief history of the biosimilars industry, the FDA's regulations and guidance for biosimilars development, and the issues and challenges facing developers and regulators in bringing biosimilars to market.
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