Tina Meinertz

Sr. Regulatory Affairs Specialist

Tina is a highly experienced senior consultant with 35 years of experience from the pharmaceutical industry hereof 15 years of regulatory CMC experience from global drug development of NCEs and Biologics from IND/CTA to NDAs/BLAs and marketed products.
Tina has prepared and developed RA CMC strategies, and has experience from regulatory project management and worldwide regulatory submissions of NDAs and BLAs, and thus she has a very strong basis for settling strategies to the benefit of the projects within the regulatory framework.

Furthermore, Tina has +10 years of experience from pharmaceutical development of solid dosage forms and injectables from early development to MAA/BLA and hereby also experience from collaboration with CMOs as part of drug development.