History

Established in 1987, Medfiles was the first private CRO in Finland. The company of 5 private shareholders and 4 employees has now grown into a business with up to about 180 experts history of 35 years. Today Medfiles is the biggest CRO in Finland by the range of services.

Please have a closer look at our history of 35 years and the company’s development.

• 1987

  In the warmth of a smoke sauna in Kuopio, an idea of a service organization for pharmaceutical companies was formed, and Oy Medfiles Ltd was established. The headquarters was naturally situated in Kuopio.

  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.

• 1993

  First clinical trials were started in Estonia.

• 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.

  The headquarters moved to new larger premises at the TietoTeknia building in Kuopio, and a satellite office in Helsinki was established.

• 1995

  The Tampere office was established.

• 1996

  Oy Medikalla Ltd (Medikalla Group) was established. The Medfiles headquarters in Kuopio moved into larger premises at the Lääketalo building on Sammonkatu. Also, the company expanded in Finland whilst an office in Oulu was established.

  The Estonian affiliate Oü Medfiles Ltd in Tartu was established, significantly expanding clinical trial services capabilities.

• 1997

  Oy Medfiles Ltd was divided into two companies. Oy Medfiles Pharma Ltd provided pharmaceutical, analytical, and microbiological services, whereas while Oy Medfiles Ltd continued focusing on clinical trials and regulatory services.

• 1998

  Data management and biostatistics services were started, and quality assurance services were supplemented with audit services.

  First GMP inspection of the laboratories was performed by the Finnish regulatory authority.

• 2000

  Services related to price and reimbursement applications were set up.

• 2001

  The Turku office was established, and the Helsinki office moved into larger premises in Espoo.

  Oy Medfiles Ltd became an affiliate to Oy Medikalla Ltd (Medikalla Group).

  Collaboration with Oy FoodFiles Ltd was started on drug–food interactions.

• 2003

  Pharmacovigilance services were established.

• 2004

  Oy Medfiles Pharma was merged into Oy MediPharmia Finland in connection with the acquisition of a production business (the Seinäjoki plant). CMO services were started.

• 2005

  GMP certification became mandatory in contract analysis business. A GMP license was applied for, and it was granted to Oy MediPharmia Ltd.

  Oy Medfiles Ltd and Oy MediPharmia Ltd merged into Oy Medikalla Ltd (Medfiles and MediPharmia
  remained as auxiliary business names, i.e. business units).

• 2006

  The headquarters moved into larger premises on Volttikatu in Kuopio enabling the laboratory facilities to expand.

  Regulatory services in the Baltic countries (Estonia, Latvia and Lithuania) were started.

• 2007

  Oü Medfiles Ltd established two subsidiaries: SIA Medfiles in Riga, Latvia and UAB Medfiles in Vilnius, Lithuania.

  PIC/S (Pharmaceutical Inspection Co-operation Scheme) Joint Visit-inspection was carried out in the laboratories by Finnish, Danish and Czech authorities.

• 2008

  A strategic decision to focus on CRO Services lead to selling the production business (the Seinäjoki plant) and terminating CMO Services. Oy Medikalla Ltd changed its name into Oy Medfiles Ltd (The auxiliary business name Oy MediPharmia Finland was terminated).

  Medical Device services were established.

• 2010

  Extending the laboratory facilities and offices in Kuopio to additional premises on Volttikatu 8 enabled considerable growth of inhalation analytics.

• 2011

  New services in health economics were established.

  The Helsinki office moved into larger premises in Vantaa.

• 2013

  The facilities for product development and stability studies were greatly expanded.

• 2014

  Food and nutrition services were established. Oy Medfiles Ltd acquired the trademark of FoodFiles and continues the services provided earlier by Oy FoodFiles Ltd. 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.

• 2016

  Pharmaceutical development services were supplemented with investigational medicinal production. A GMP license extension was applied for and granted.

  Microbiological laboratory function moved to new premises on Neulaniementie (Bioteknia) in Kuopio.

• 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, the USA, and India.

  Collaboration with the newly launched CIOMS Working Group was established.

• 2018

  New services, production, packaging and labelling of Investigational Medicinal Products (IMP) were started. Medfiles’ Global collaboration and networks were developed and strengthened through our sister companies within WDB Group in Japan, the USA, and India. Sales office in Tokyo, Japan was opened.

• 2019

  Medfiles started collaboration with its US-based sister company, DZS Clinical Services. Also, other international activities were developed further.

  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.

  The Helsinki office space in Vantaa was expanded.

• 2020

  Close collaboration with DZS by joint clinical service projects. New services introduced throughout the business units including a rotary benchtop tablet press and improvements on EU release and PV service.

• And development continues…

  The small company of a couple of people has over the years grown into a business of almost 200 employees. Today, Oy Medfiles Ltd is one of the oldest and largest CROs in the Nordic and Baltic countries – an independent, privately-owned company with a comprehensive range of services.