Dana Nohynek, MSc, RAC (she/her/elle)

Regulatory Strategy and Compliance

Vancouver, BC

Dana Nohynek, MSc, RAC, is a regulatory strategy and compliance advisor who lives and works on the traditional, unceded territories of the xʷməθkwəy̓əm (Musqueam), Sḵwx̱wú7mesh Úxwumixw (Squamish), and səl̓ílwətaɬ (Tsleil-Waututh) Nations. She works with start-up and clinical-stage biotech organizations to advance therapeutic and medical device programs through the development pathway to market approval. Her expertise includes developing and executing regulatory strategy, liaising with regulatory agencies during product development and through marketing submission, clinical development planning, and providing regulatory perspectives for corporate strategic planning. Dana is actively involved in the development of psychedelic and cannabis as therapeutic products.

Dana has experience with small to mid-size biotech and medical device companies as well as with large pharmaceutical companies. Her industry experience includes the development of regulatory strategies throughout various phases of clinical investigation; submissions to health agencies in the United States, Canada, and Europe; implementation and maintenance of quality assurance systems; preparation and participation in agency audits; and the development of internal training programs.

Services offered:

  • Regulatory strategy
  • Submission to regulatory authorities and REBs/IRBs
  • Clinical development planning
  • Regulatory compliance