November 22, 2017

Kim Tyrrell-Knott

Kim Tyrell-Knott is a Member of the Firm in the Health Care and Life Sciences practice, based in San Diego and Washington, DC, and serves on the firm's National Health Care and Life Sciences Steering Committee. She has significant experience advising investors and companies on a broad range of health care regulatory issues and developing and implementing comprehensive compliance programs. Ms. Tyrrell-Knott also has extensive experience assisting new entrants to the FDA regulated environment, from mobile app developers to compounding pharmacies, in understanding and complying with the applicable regulatory requirements.

  • Assists medical device and health care technology companies with FDA-regulation compliance throughout the product life cycle—from product development to post-market compliance

  • Conducts health care regulatory due diligence for transactions involving health care technology or medical devices companies

  • Advises private equity and financial services firms on the regulatory issues associated with corporate transactions

  • Counsels clients on clinical research issues, including drafting and negotiating clinical research agreements

  • Assists clients in creating and implementing compliance programs addressing FDA, clinical research, data privacy, and fraud and abuse regulatory requirements

  • Advises health care and technology companies on complex commercial transactions, including strategic technology partnerships and software licensing arrangements

  • Advises clients on regulatory requirements for compounding pharmacy operations, including FDA warning letter responses

Articles in the National Law Review database by Kim Tyrrell-Knott

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