Marie Gårdmark CEO and Senior consultant
M Sci Pharm, Ph D
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 actively contributed 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 Senior consultant
M Sci Pharm, Ph D
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 Senior consultant
M Sci Pharm, PhD
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.
Emil Schwan Senior consultant
M Sci Pharm
Emil is a pharmacist with experience from performing GMP and GDP inspections, formulation development, manufacturing of medicinal products and pharmaceutical quality systems. He has been chief designer for several types of medicinal products.
Most recently Emil comes from the Swedish Medical Products Agency, where he spent eight years as a pharmaceutical inspector. As an inspector he inspected sites in Sweden and in countries outside EU, e.g. China, India, USA. He has extensive knowledge in GMP and GDP for both medicinal products and active pharmaceutical substances. He knows the peculiarities of special types of products, e.g. medicinal gases, and investigational medicinal products as well as special types of operations, e.g. shipping of cold store products and applying safety features (serialisation) on medicinal packages.
With a background in product development as well as in inspecting Emil strives to find solutions that are fit for purpose, doing the job, and removing difficulties!
Robert Hägerkvist Senior consultant
M Sci Pharm, Ph D
Robert is a pharmacist with a PhD in medical cell biology.
Most recently, Robert comes from the Swedish Medical Products Agency, where he spent eight years as a clinical assessor. As a clinical assessor he has reviewed a number of market authorisation applications as well as providing scientific advice to companies. He has extensive knowledge in regulatory pathways in the pre- and post-marketing setting. Previous to his position as a clinical assessor, Robert spent five years at the Swedish Poisons Information Centre learning clinical toxicology and the importance of efficient communication. Over the years, Robert has been involved in various projects broadly related to medicinal products, ranging from new psychoactive substances to various borderline products.
With a firm background as a regulator Robert strives to find solutions, that are fit for purpose and makes scientific sense.
Katarina Andersson Senior consultant
B Sc in Pharmacy
Katarina has a long-standing experience as a pharmaceutical inspector, pharmacovigilance (GVP).
Most recently, Katarina comes from the Swedish Medical Products Agency (MPA), where she spent twelve years as an inspector, whereof the last six years as Head of the GVP/GCP group of inspectors. She has extensive knowledge in pharmacovigilance and has been a delegate in the Pharmacovigilance Inspector Working Group at the European Medicines Agency for several years.
The work as inspector has included inspection of national sites as well as European sites and in countries outside EU, e.g., India and USA. The Marketing Authorisation Holders (MAH’s) inspected have ranged from small MAH’s to multinational companies.
In addition, she has 13 years of experience from the pharmaceutical industry in clinical trials and pharmacovigilance.
With long experience in the area of GVP Katarina can provide valuable insight in achieving efficient and well-functioning pharmacovigilance systems in accordance with the regulations.
Brita Liljestrand Senior consultant
Registered Nurse, B Sc in Electronic Engineering, Master of Public Health
Brita is an expert in medical device regulations (MDD/MDR) and has a long experience of use and maintenance of medical devices in the health care environment.
She has a long regulatory background and has worked for the Swedish Medical Products Agency (MPA) for the last 12 years. Brita has worked with inspections of manufacturers and she has been auditing notified bodies in Sweden. She has also participated as a national expert for the Commission in the work of assessing notified bodies according to MDR in other member states in Europe.
At the authority she has also been working with supervision of post market surveillance and vigilance systems. This included reviewing quality management systems and risk management processes of medical devices.
Beside the experience at the authority, she has a broad clinical background which means that her strength lies in knowledge of usability and to detect and define risks. Brita has worked as a nurse in several different types of hospital wards. She has also worked as a biomedical engineer with repairment and maintenance of different medical devices. This makes her aware of the technical issues affecting performance and safety of the devices.
Brita has also experience of working with procurements at county council being responsible for purchasing medical devices for hospitals and dispensaries.
The main goal for Brita is to find solutions for medical devices that are safe, fit for purpose and regulatory compliant.
Sophie Bertilsson Senior consultant
Sophie has broad experience of the pharmaceutical aspects of drug development. She has over 15 years of experience as project manager as well as expert in the pharmaceutical industry, where her main focus areas have been development and GMP manufacturing of active pharmaceutical substances, drug product supply to clinical trials, and regulatory CMC aspects. The regulatory expert role included development and implementation of global regulatory CMC strategies for projects up until market approval, authorizing regulatory documentation, interactions with health authorities as well as activities related to in- and out- licensing.
Most recently, Sophie comes from the Swedish Medical Products Agency, where she spent four years as a chemistry and pharmaceutical assessor. Her responsibilities included provision of scientific advice, review of clinical trial applications as well as market authorization applications and variations.
Sophie has experience of a wide variety of drug formulations and has also assessed new chemical entities.
She has a special interest in impurities and new manufacturing methods.