Martina Nora Šotolová, MPharm

Pharmacist by education, with diploma in the analytical chemistry, Nora gained professional experience in Zentiva, Prague, Czech Republic, in the analytical R&D. She participated in various levels of pharma development, e.g. development/validation/transfer of analytical methods for numerous new products, dissolution method development, stability testing, portfolio care etc. She was involved in implementing CTD for Module 3 texts, and led the documentation department for responding the deficiency letters of Registration Authorities. Later in her career she became part of a consultancy company Pharminvent and further specialized in regulatory strategies, assisting the clients with Module 3 contents and related tasks, including but not limited to QOS, impurities assessment, in vitro data analysis, briefing packages for SA and biowaivers justification. 

As an independent consultant, Nora specializes mainly in the CMC part of pharma development. She helps clients navigate regulatory expectations and structure their Module 3 or IMPD-Q documentation effectively, concisely and with clear focus on the development phase. Nora further specializes in regulatory biowaivers of various types, including BCS-based biowaivers, offering deep understanding of the quality of in vitro data to be generated for granting the biowaiver. She contributed to numerous successful marketing authorization submissions.