NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Mark D. Weiss, MS, MA

Practice Area Focus

  • Biosimilars
  • Drugs
  • NCEs
  • Gene Therapy
  • Generics
  • CMC (IND, NDA, DMF, briefing packages)
  • Compliance
  • Quality Systems

Biography

Mark Weiss joined NDA Partners as an Expert Consultant in 2017. He has more than 35 years of diversified pharma and biopharma CMC-related and medical device experience. Mr. Weiss consults in the management, writing, and preparation of complex submissions and regulatory documentation, including CTD and eCTD documentation and source documentation that conforms to FDA, EMA, and ICH requirements. His experience also includes formulations development and troubleshooting, batch record development and preparation, analytical methods development, validation, troubleshooting, and scientific and technical writing.

Mr. Weiss was formerly Principal Scientific and Technical Writer at Purdue Pharma and has consulted in a wide variety of CMC-related and other capacities for Juno Biotherapeutics, TherapeuticsMD, bluebird bio, Upsher-Smith Laboratories, Pfizer Biotech, Taiho Oncology, Merck, Ipsen Biomeasure, and others. In his early career, he was a Pharmaceutical Chemist and Pharmaceutical Formulationist, Analytical Development Chemist, and Medical Writer at Lederle Laboratories.

Mr. Weiss is a member of the American Medical Writers Association and the American Chemical Society.