Niamh has been with NDA since 2010 and excels at advising companies on their development strategies to meet expectations of regulatory agencies throughout product development. She applies her skills to a broad range of product types including biological, biotechnological, biosimilar and advanced therapy medicinal products. Niamh has successfully helped numerous clients develop their products and interact with regulatory agencies throughout the stages of development and during regulatory review.
Key Areas Of Expertise
- Global strategic CMC and regulatory support for the development of medicinal products during preclinical development and throughout the product lifecycle:
- Supporting the development of > 100 biological, biotechnological, biosimilar and advanced therapy products throughout all phases of development.
- Product development:
- Providing strategic advice on comparability programmes for biological, biotechnological, biosimilar and advanced therapy products at all stages of process development.
- Niamh conducts assessments of chemical-pharmaceutical documentation for ATMPs, biotechnological and biological medicinal products to determine the appropriateness of the documentation for global regulatory submissions (CTA, IND, MAA, NDA and BLA).
- Global CMC document preparation:
- Involved in the preparation and evaluation of CMC documentation for IMPDs, INDs, global DMFs, scientific advice briefing documents, FDA meeting documents, MAAs, NDAs and BLAs, including preparation of Quality Overall Summaries and strategic input and preparation of responses to global agency CMC questions.
- Procedural support:
- Involved in the management and execution of regulatory procedures e.g. clinical trial applications, INDs, Agency meetings (EU and US), ATMP classification, ATMP Certification, Orphan Drug Applications.
Niamh has worked in regulatory consulting groups where she provided CMC regulatory support to clients developing products at all stages of the product lifecycle. She also spent a number of years working for a biotech company in the CMC department developing products for Phase 1 clinical development.
Niamh has a PhD in prokaryotic molecular biology and has 7 years of post-doctoral research in prokaryotic molecular biology investigating microbial pathogenicity and virulence factors.
Dr Niamh Kinsella