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Sharon Bradley specializes in counseling pharmaceutical and medical device companies on a broad spectrum of regulatory and compliance matters, including advertising and promotion, healthcare fraud and abuse, and transactional due diligence.  With an emphasis on providing practical, solutions-oriented advice, Sharon frequently serves as counsel on promotional review committees and has extensive experience advising clients on product launch strategies and lifecycle management.

Sharon has over 15 years of experience advising manufacturers of FDA-regulated products, both as external counsel and as senior in-house regulatory counsel at a global pharmaceutical company.  She regularly assists clients with:

  • Designing and implementing healthcare compliance programs
  • Conducting compliance risk assessments and gap analyses
  • Preparing and delivering regulatory and compliance training to internal stakeholders, ranging from field-based sales representatives to the C-suite
  • Assessing and responding to competitor complaints
  • Conducting internal investigations and responding to government inquiries

Sharon is also a frequent speaker at industry conferences.  She graduated with honors from the George Washington University Law School, where she was a member of the George Washington Law Review.

Full Bio

Credentials

J.D., George Washington University Law School, with honors

District of Columbia

New York

U.S. Court of Federal Claims

U.S. District Court for the Southern District of New York

Matters

Develops comprehensive compliance programs for pharmaceutical, medical device, and dietary supplement manufacturers.

Serves as outside counsel on pharmaceutical and medical device companies' promotional review committees.

Conducts internal investigations on behalf of pharmaceutical and medical device companies in response to inquiries from FDA and other governmental entities.

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Matters

Develops comprehensive compliance programs for pharmaceutical, medical device, and dietary supplement manufacturers.

Serves as outside counsel on pharmaceutical and medical device companies' promotional review committees.

Conducts internal investigations on behalf of pharmaceutical and medical device companies in response to inquiries from FDA and other governmental entities.

Advises pharmaceutical and medical device manufacturers on compliant scientific exchange.

Conducts compliance assessments for pharmaceutical and medical device companies and devises strategies for minimizing compliance risks.

Drafts corporate contracts for pharmaceutical and medical device companies related to consulting, manufacturing, licensing and clinical trials.

Conducts regulatory due diligence in association with acquisitions of pharmaceutical products and companies.

Matters

Develops comprehensive compliance programs for pharmaceutical, medical device, and dietary supplement manufacturers.

Serves as outside counsel on pharmaceutical and medical device companies' promotional review committees.

Conducts internal investigations on behalf of pharmaceutical and medical device companies in response to inquiries from FDA and other governmental entities.

See more
Icon close

Close

Matters

Develops comprehensive compliance programs for pharmaceutical, medical device, and dietary supplement manufacturers.

Serves as outside counsel on pharmaceutical and medical device companies' promotional review committees.

Conducts internal investigations on behalf of pharmaceutical and medical device companies in response to inquiries from FDA and other governmental entities.

Advises pharmaceutical and medical device manufacturers on compliant scientific exchange.

Conducts compliance assessments for pharmaceutical and medical device companies and devises strategies for minimizing compliance risks.

Drafts corporate contracts for pharmaceutical and medical device companies related to consulting, manufacturing, licensing and clinical trials.

Conducts regulatory due diligence in association with acquisitions of pharmaceutical products and companies.

Credentials

J.D., George Washington University Law School, with honors

District of Columbia

New York

U.S. Court of Federal Claims

U.S. District Court for the Southern District of New York