Anna Longwell, Esq. Curriculum Vitae

 

Regulatory Attorney, and Principal, Longwell and Associates

Completed a successful 30-year career in the medical product industry, from a product development scientist at the (then) newly formed Alza corporation to VP Regulatory for two Becton Dickinson divisions, BD Medical and BD Immunocytometry Systems. In 2003, Ms. Longwell started her own law firm in Palo Alto, to assist FDA-regulated companies in their interactions with FDA.

Since 2004, Ms. Longwell and her associates have assisted companies in the drug, device, IVD, biologic, food, and tobacco product area. She has assisted with regulatory strategy, marketing submissions including PMA, BLA, NDA, s-NDA and ANDA, plus ex-US submissions in the EU and Canada. She has audited existing systems for regulatory compliance in the development, manufacturing, labeling and advertising of in vitro diagnostic products and new drugs and implemented such systems for start-up companies . She has assisted venture capitalists in due diligence evaluations of financing opportunities. Her current interests are in the areas of molecular medicine and medical diagnostic software products, concentrating on design control, product claims and claim validation.

Education and Professional Certificates

Ms. Longwell holds a bachelor’s degree in Chemistry from San Francisco College for Women (now USF), a Master’s degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively.  She is a current member of the California Bar (#166040) and the US Patent bar (#50629).

Work Experience

  • Stanford Medical School; Laboratory Assistant 1959-1960
  • SRI-Research Chemist, space program 1961-1971
  • Alza Corporation, research scientist 1971-1982
  • Consulting, Collagen Corp, other medical product firms, 1982-1983
  • From consultant to VP Regulatory Affairs: Becton Dickinson Immunocytometry Systems 1983-1998
  • Corporate VP Regulatory Affairs, Becton Dickinson Medical Systems 1998-2001
  • Consultant, BD Immunocytometry Systems 2001-2003
  • Principal, Longwell and Associates 2003-Present.  Clients in the Drug, Biologics and Medical Device (concentration on IVD) areas

Skills

  • Negotiation, Resolving complex regulatory legal questions
  • Communication: Explaining conflicting positions, finding common ground, developing strategies for efficient regulatory compliance
  • Training individuals for significant careers in Regulatory Affairs: Have developed one RA VP and three RA Directors from junior positions
  • Helping startups with their first regulatory interaction