Who we are


Marie Gårdmark, Ph D, CEO and senior consultant

Marie has a wide range of experience from drug development. She has more than 10 years’ experience as a regulator at the Medical Product Agency in Sweden (MPA), a major contributor to EU regulatory decision making.  As Director of Licensing at MPA she was responsible for activities and decisions related to drug approvals and life cycle management including clinical trials and scientific advice.  She led the agency’s work with innovation support. Her responsibility covered products of both biological and chemical origin within human and veterinary medicine. As a regulator she has activelycontributed to development of new guidelines and legislation.

Dr Gårdmark has 10 years of experience from senior roles in small and big pharma companies mainly in Regulatory R&D as exemplified by development and implementation of global regulatory strategies, due diligence activities and scientific advice meetings in EU and US. Her main focus has been in clinical and preclinical research.

Her scientific background is in clinical pharmacology and pharmacometrics and she has several years of experience from early drug development. She holds a PhD in pharmacokinetics from Uppsala University, Sweden.

Marie Gårdmark is co-founder of RegSmart Life Science AB.

Agneta Larhed, Ph D, senior consultant

Dr Larhed has a broad experience within formulation development and regulatory quality documentation. She has been a pharmaceutical quality assessor at the Swedish MPA, where she recently was the Senior scientific manager within chemistry/pharmaceutics, which included the responsibility for the overall scientific quality assurance of pharmaceutical quality assessments. Agneta is an expert in the Ph. Eur. Expert group Dosage Forms and Dosage Forms Methods and was one of the delegates for Swedish MPAs to the European Pharmacopoeia Commission.

She has been active as a researcher and manager within both academic and industrial pharmaceutical innovation and product development for more than 10 years. Her work focused on drug absorption, drug delivery and formulation development, covering a range of formulations and dosage forms such as tablets, gels and microparticles.

In addition, she has been involved in the development of courses and symposia and is currently a board member of the scientific section Pharmaceutics in the Swedish Academy of Pharmaceutical Sciences.

She obtained her PhD at the department of Pharmaceutics at Uppsala University, Sweden.

Agneta Larhed is co-founder of RegSmart Life Science AB.