History
In 1987, in the warmth of a smoke sauna in Kuopio, the idea of a service organisation for pharmaceutical companies was born, and so, Oy Medfiles Ltd was established as the first private CRO in Finland.
The company of five private shareholders and four employees has now grown into a business with some 95 experts and a history of over 35 years. We have accumulated extensive expertise across a wide range of product categories, including human and veterinary pharmaceuticals, food, feed, medical devices, and IVDs.
During these years, Medfiles has expanded its activities globally and is striving to strengthen its position in the market. We will continue concentrating resources and expertise on our primary services; regulatory affairs, pharmacovigilance and clinical research.
We enhance our clients’ business value through collaborative efforts and smooth service experience. This is how we build long-term relationships with our clients and work together to “Securing a Healthier Tomorrow”.
1987
An idea of a service organisation for pharmaceutical companies was formed, and Oy Medfiles Ltd was established. Initially, the company offered services in chemical analysis of pharmaceutical raw materials and finished products.
1990
Services related to clinical trials, regulatory affairs, marketing authorisations as well as microbiological analyses began.
1994
Medfiles was granted a medicinal product manufacturer’s licence which allowed Medfiles to package, label, randomise and distribute investigational medicinal products to study sites.
1998
Quality assurance services were supplemented with audit services. First GMP inspection of the laboratories was performed by the Finnish regulatory authority.
2003
Pharmacovigilance services were established.
2005
GMP certification became mandatory in contract analysis business. A GMP license was applied for, and it was granted.
2008
Medical Device services were established.
2010
Services for inhalation analytics were significantly expanded.
2014
Food and nutrition services were established. The services in food and nutrition and non-drugs strengthened the company’s position in the interface of medicinal and food products significantly. Qualified person (QP) services were established.
2015
A GMP license extension was applied and granted for extending laboratory services with sterility and endotoxin testing.
2017
Oy Medfiles Ltd was acquired by WDB Holdings enhancing the potential for Medfiles to grow globally in cooperation with the sister companies in Japan and the USA.
2018
Pharmaceutical development services were supplemented by adding the production, packaging and labelling of Investigational Medicinal Products (IMP) to the service portfolio. Medfiles’ global collaboration and networks were developed and strengthened through our sister companies within WDB Group in Japan and the USA.
2019
Investments in R&D and IMP services and non-drugs sector strengthened the service portfolio, reinforcing the company’s position on the interface of medicinal and non-drug products.
2020
New services introduced throughout the business units including a rotary benchtop tablet press and improvements on EU release and PV service.
2025
The laboratory business was sold, and the future focus will be on clinical trials, regulatory and pharmacovigilance services.