Anna Axelman

Senior Advisor
MSc Chemistry/Biology

anna.axelman@regsmart.se +46 (0) 70 535 07 22

Anna is a senior pharmaceutical development professional with more than 30 years of multidisciplinary experience across large and small pharmaceutical companies. With a background as an analytical chemist, she has in‑depth expertise in CMC regulatory strategy and a strong track record in project and cross‑functional team management.

More about Anna

Anna brings broad CMC regulatory experience from early preclinical development of NCEs through late‑stage product development, covering a wide variety of formulations such as solutions, sublingual products, immediate‑release, and delayed‑release formulations. She has extensive experience in preparing for regulatory advice and MAA/NDA submissions, with regulatory interactions not only with the EMA and FDA, but also with health authorities in regions including China, Japan, Singapore, Taiwan and South Korea.

Before joining RegSmart, Anna held the role of Associate Project Director at Calliditas Therapeutics, where she played a key role supporting critical decisions related to product development and market positioning.

Anna is passionate about supporting clients by integrating CMC regulatory strategy into pharmaceutical development to drive efficient project execution.