Senior Consultant

Dr Janet Makowska

Janet has been with NDA since 2001 and has extensive experience of non-clinical development throughout the product lifecycle. She specialises in authoring/reviewing non-clinical documentation to meet expectations of regulatory agencies.

Key Areas Of Expertise
  • Extensive experience of nonclinical development throughout the product lifecycle
  • Nonclinical and regulatory advice at all levels of product development, from early development through MAA/NDA/BLA to post-approval
  • Preparation and compilation of nonclinical documentation for MAA/NDA/BLA, including preparation of Nonclinical Overview (Module 2.4), Nonclinical Summaries (Module 2.6) and nonclinical sections of Risk Management Plan
  • Strategic input and preparation of responses to agency non-clinical questions
  • Preparation and review of a variety of nonclinical documentation during product development (IB, IMPD, IND, CTA, Scientific Advice, Briefing Documents, PIP, ATC applications)
  • Preparation of nonclinical gap analysis for products prior to or post MAA submission
  • Experience in the preparation of Phase I environmental risk assessments
Before NDA

Janet completed a post-doctoral fellowship in toxicology followed by positions in regulatory affairs at TIL Occam, Medeva Pharma and Celltech.

Janet has a BSc (Hons) Biological Sciences, MSc Toxicology, MSc Pharmaceutical Sciences, and a PhD in Toxicology.

Dr Janet Makowska


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