SweDeliver Webinar • Marie Gårdmark

Welcome to the SweDeliver webinar series. This time, we are delighted to host Marie Gårdmark, CEO of RegSmart Life Science AB, a Uppsala‑based consultancy specializing in regulatory support for pharmaceuticals and medical devices. Marie will give a presentation titled “Regulatory strategy in drug development” sharing her expertise in navigating the complex regulatory landscape.

Marie Gårdmark is the CEO, co‑founder, and Senior Advisor at RegSmart Life Science AB, with more than 25 years of experience in drug development, regulatory affairs, and pharmaceutical strategy. She holds both an MSc in Pharmacy and a PhD in pharmacokinetics from Uppsala University. Her scientific background includes clinical pharmacology, pharmacometrics, and early drug development. She spent more than 10 years as a regulator at the Swedish Medical Products Agency (MPA), where she was a major contributor to EU-level regulatory decision-making. As Director of Licensing, she oversaw drug approvals, clinical trials, life cycle management, scientific advice, and innovation support. Further, she has held senior regulatory positions in both large pharmaceutical companies (including AstraZeneca) and smaller research-driven firms, focusing on global regulatory strategy, due diligence, and regulatory interactions with the EMA and FDA. As CEO, RegSmart Life Science AB, she leads a consultancy that supports small and mid‑sized life science companies with regulatory strategy, post‑approval requirements, and product development planning.

Read more Regsmart Life Science AB here