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 180 experts and a history of over 35 years. Medfiles has evolved from a chemical analysis supplier to a one-stop service provider covering the entire development and lifecycle management of healthcare products. Today, our clients include pharma companies, medical device and IVD businesses as well as food, feed and cosmetic businesses.

Medfiles has expanded its operations within Europe and outside of Europe and is on its way to an even wider market. At the same time, we are committed to building long-term relationships with our current clients. Client experience is at the heart of everything that we do.

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.

2022

Medfiles expanded its operations to Sweden and established a branch office in the Gothenburg region. The Food & Feed unit expanded its service portfolio to include cosmetics.