Guidehouse

David M. Berger

Director

Life Sciences

Lawrenceville, NJ +1.609.219.8731

Areas of Expertise

David Berger is a Director in our Life Sciences practice, where he leads the Regulatory Affairs, Quality and Patient Safety group.  A lawyer by training, he has over 20 years of strategic leadership experience, including having served as General Counsel for pharmaceutical and life sciences companies. David provides advisory support to life sciences companies related to FDA (and equivalent international agencies) regulations and requirements for bringing products (drugs, devices and diagnostics) to market and keeping them on the market.

More specifically, he advises on global regulatory strategy, labelling, regulatory submissions (IND, NDA, ANDA, 505(b)(2), BLA, 510(k) and Rx to OTC switch), quality management systems, and product lifecycle strategies.  David’s experience includes: developing strategies for regulatory affairs and quality assurance teams in connection with FDA matters and proceedings (including Type A, B and C meetings and appeals); leading multi-disciplinary teams in response to Warning Letters and 483s and conducting mock audits; establishing promotional review committees, policies, procedures, as well as databases for collateral; advising on pharmacovigilance matters; reviewing advertising and promotional collateral for compliance with OPDP/FDA rules, regulations and guidance; and managing and overseeing clinical trial agreements (including informed consent forms, study protocols and IRB proceedings).

Additionally, David has deep experience with Mergers and Acquisitions (M&A) having negotiated and advised Boards of Directors on M&A transactions ranging from transformational multi-billion-dollar transactions to discrete asset purchases/sales.  He has served as Integration Team Lead for various transactions and has advised on due diligence, pre- and post-merger strategy, integration, organizational design and change management issues. During David’s tenure as General Counsel, he also regularly provided advice on IP strategy, as well as branded and generic product launches.

Education
J.D., summa cum laude, American University Washington College of Law
B.A., cum laude, English, Villanova University
Certifications
Admitted to the New York Bar.
Admitted to the New Jersey Bar

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David Berger

David M. Berger

Director

+1.609.219.8731

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