Regulatory Experts

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.

Ira Palminger Hallén, PhD, Senior consultant

Ira has over ten years’ experience as a regulatory expert covering nonclinical and clinical drug development. She has been a nonclinical assessor at the Swedish Medical Product Agency (MPA) reviewing toxicological/pharmacological documentation in drug applications from early development to market approval. Furthermore, Ira was Clinical Assessor at the Norwegian Medical Agency (NoMA) reviewing clinical trial applications in all therapeutic areas, with primary focus on oncology. With her regulatory background, Ira has vast experience from giving scientific advice at the national level in Sweden and Norway and she was working at the EMA-level as coordinator and assessor of central scientific advices. The last three years Ira has been working as senior regulatory consultant, supporting clients with regulatory scientific reviews as well as preparation of various documentation for Agency interactions. She covers products of both biological and chemical origin within human medicine. Ira has in-depth knowledge of EMAs regulatory procedures, and the applicability of regulatory guidelines and legislations.

In addition, Ira has twelve years of experience from R&D at AstraZeneca, initially as a Toxicologist working with drug distribution. Subsequently as Sr Clinical Pharmacology Scientist accountable for the clinical pharmacology program in Neuroscience projects including contributions to clinical development plans, study designs and CTA documentations. 

Ira holds a PhD in Toxicology from Uppsala University in the area of reproductive toxicology. 

Peter Fröberg, Director Medical Device, Senior Consultant

Peter has a long and broad experience from the global medical device sector working with the complete product life-cycle, never losing sight of the market. Peter is a solution-oriented person with a strong record from strategic regulatory decision-making roles and he perfectly matches our motto “fit-for purpose”. Peter is responsible for building RegSmart’s medical device service, offering strategic and regulatory advice to the clients. 

The goal is to identify solid and pragmatic solutions and to convey knowledge, enabling a smooth transition into the changing regulatory landscape and to shorten time to market. With a background in engineering and product development, and many years as product manager within the medical device sector building strong, trustful relations have resulted in solving many strategic and regulatory obstacles along the way.

To put it short; A person who finds joy in the process of creation, solving problems and conveying knowledge amongst dedicated and talented people!