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

LinkedIn

Stay up to date

Contact Us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World