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Sarah Cowlishaw is a partner in the Life Sciences Practice Group, whose practice focuses on life sciences regulatory and commercial law. She serves as one of the leaders of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and marketing of digital health technologies.

Ms. Cowlishaw advises major national and multinational pharmaceutical companies and biotechnology, diagnostic, medical device, and consumer product manufacturers on a wide range of regulatory, compliance, transactional, and legislative matters. Her advice on general regulatory matters includes borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion.

  • Regulatory and commercial advice on digital health and health information issues to clients in the life sciences and software technology industries.
  • Regulatory advice on product classification issues, including the borderlines between medicines, medical devices, cosmetics and combination products.
  • Regulatory and commercial due diligence for pharmaceutical, medical device and food companies.
  • Negotiation and review of life sciences commercial arrangements, including clinical trial agreements, wholesaler arrangements and pharmaceutical manufacturing and supply contracts.
  • Participation in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, clinical trials, and pharmacovigilance rules.
  • Co-ordinating international projects on advertising/promotion and clinical research.

Pro Bono

  • Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
  • Assisting in a pro-bono project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Previous Experience

  • Secondment to the in-house legal department of a multinational pharmaceutical company.
  • Secondment to the in-house legal department of an international pharmaceutical company, based in Germany.