who we are
Medfiles is one of the largest full-service Contract Research Organization (CRO) in the Nordic and Baltic countries. Established in 1987, we have grown to an organization of more than 130 pharmaceutical professionals who operate globally. We have four offices in Finland as well as offices in Estonia, Latvia and Lithuania. Our state-of-the-art laboratories are located in Kuopio, Finland and employ more than 50 professionals.
Medfiles offers a full range of services, from the development and regulatory phases through to services for marketed products. Our service portfolio includes:
•Pharmaceutical development and analytical services
•Sterility and endotoxin testing
•Phase I–IV drug studies (in humans and animals)
•Medical device investigations
•Food and nutrition studies
•Regulatory affairs related to human and veterinary medicines and food and nutrition
•Health economics/market access
•Medical and regulatory writing
•Qualified Person (QP) activities
Our high-quality services, wide range of domestic and foreign clients and partner networks create a firm basis to extend our current service portfolio and to develop novel services and new business models – for your needs. Our aim is to build long-term, fruitful collaboration with you - creating continuous added value to both of us.
Our expert-driven organization provides expertise to develop your product and meet the regulatory requirements and the “one-stop-shop” service package offers you rapid, fluent and cost-effective way of outsourcing your activities.
what we are looking for
Medfiles serves customers that develop, manufacture or market, pharmaceuticals or biologics, for either human or veterinary use, in vitro diagnostic products and medical devices, as well as food and nutrition products.
Tuija Keinonen, PhD (Pharm)
Tuija Keinonen was CEO of Medfiles Ltd between 1999 and 2005 and is CEO of Medfiles Group since 2005. She has over 20 years of experience in the contract research business and its establishment. She has now led Medfiles Ltd and been a member of the board for over 14 years. Before this position Tuija Keinonen was Medfiles’ clinical research director (and 4 years as the quality director responsible for the establishment of the company’s quality system).
Before Medfiles she worked as a deputy pharmacist in charge of a hospital pharmacy (Vaajasalo hospital) and as project researcher (pharmaceutical chemistry) at the University of Kuopio. In 2003, Tuija Keinonen defended her doctoral dissertation (Clinical Drug Trials in Finland: Quality and Characteristics) on pharmacology and toxicology at the University of Kuopio. She has published scientific articles on clinical trials and pharmaceutical chemistry.
Furthermore, Tuija Keinonen led a contract manufacturing organization, Medipharmia Finland Ltd, a former subsidiary of Medfiles Group (the former Medikalla Group) for over 3 years. She has experience in business acquisitions and business integration. She holds several positions of trust both in the private and public sector as well as board memberships. She is a frequently invited speaker at courses and seminars. Tuija Keinonen has also been an Estonian honorary consul (appointed by Ministry of Foreign Affairs of Estonia) since 2012.
Satu Kujala, MSc (Pharm)
Satu Kujala has been with Medfiles since 1999. She worked as a clinical research director until 2006 and then as a regulatory affairs director until June 2014 when she was appointed the director of healthcare services. Currently, she is in charge of Medfiles’ clinical, regulatory, pharmacovigilance, and health economic services. She has worked for over 20 years in pharma industry and has gathered experience in clinical trials, regulatory affairs, price and reimbursement applications, pharmacovigilance, quality, and marketing.
Satu Kujala has acted as the QPPV for Oy Medfiles Ltd since 2007 and also for several companies. She has also worked as a responsible director of the wholesale for several companies and as a QA responsible for an ISO9000 certified company. Her experience in clinical studies covers 12 years as a CRA, project manager, and research director with various duties ranging from study planning to writing of a final study report. She has also been a lecturer at the University of Helsinki and worked in a pharmacy.
Satu Kujala has broad knowledge of drug development and life-cycle management as well as a long track record in the CRO business with wide range of duties from those of a scientific expert to marketing and business unit management
Mirja Savolainen, MSc (Biochem)
Mirja Savolainen has led the R&D and analytical services unit at Medfiles Ltd since 2007. Before that she worked for 10 years as a laboratory manager of the microbiological laboratory: her main responsibility was to set up and develop microbiological services. Before Medfiles she held various teaching positions on laboratory techniques in microbiology and cell biology at the University of Kuopio.
Mirja Savolainen has also been the responsible director of Medfiles Ltd since 2008; this is a mandatory position stipulated by the Finnish Medicines Act for every company with a GMP license. She has experience in quality issues as well as occupational safety. She has a long track record in the CRO business with a wide range of duties from those of a scientific expert to marketing and business unit management.
Full list of offices and contact personnel: http://medfiles.eu/contact_us