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 were naturally situated in Kuopio.
Initially, the company offered services in analytics and pharmaceutical analyses of raw materials.
Services related to clinical trials, regulatory affairs, marketing authorisations as well as microbiological analyses were started.
Clinical trial services were started in Estonia.
Medfiles was granted the right to operate as a pharmaceutical company allowed to package, label, randomize and distribute investigational medicinal products to study sites.
The Kuopio HQ moved into larger premises in TietoTeknia building, Savilahdentie, Kuopio.
The Helsinki-office was established.
The Tampere office was established.
Oy Medikalla Ltd (Medikalla Group) was established. The Kuopio HQ moved into larger premises in Lääketalo building, Sammonkatu, Kuopio.
The Estonian affiliate Oü Medfiles Ltd, Tartu, was established. Clinical trial services were greatly expanded.
The Oulu office was established.
Oy Medfiles Ltd was divided into two companies. Oy Medfiles Pharma Ltd continued providing pharmaceutical, analytical, and microbiological services. Oy Medfiles Ltd concentrated on clinical trial services.
Regulatory services were greatly expanded.
Data management and biostatistics services were started. Quality assurance services were supplemented with audit services.
First GMP inspection in the laboratories was performed by the Finnish regulatory authority.
Services related to price and reimbursement applications were set up.
The Turku office was established.
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.
Pharmacovigilance services were established.
Oy Medfiles Pharma was merged into Oy MediPharmia Finland in connection with acquisition of a production business (the Seinäjoki plant). CMO services were started.
GMP certification became mandatory in contract analysis business. A GMP licence was applied for and it was granted to Oy Medfiles Pharma 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).
The Kuopio HQ moved into larger premises in Volttikatu 5, Kuopio, and the laboratory facilities were greatly expanded.
Regulatory services in the Baltic countries (Estonia, Latvia and Lithuania) were started.
Oü Medfiles Ltd established two affiliates: 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.
The production business (the Seinäjoki plant) was sold and CMO services were therefore terminated. The company decided to focus on CRO services only.
Oy Medikalla Ltd changed its name into Oy Medfiles Ltd (MediPharmia business unit was terminated).
Medical device services were established.
The laboratory facilities were greatly expanded with the premises of Volttikatu 8, Kuopio.
Services in inhalation analytics were established and greatly expanded.
Services in health economics were established.
The Helsinki office moved into larger premises in Vantaa.
The facilities for product development and stability studies were greatly expanded.
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 strengthen the company’s position in the interface of medicinal and food products significantly.
Qualified Person (QP) services were established.
Staff: about 150
The laboratory facilities were greatly expanded with the cleanroom facilities (grades A through D) in Neulaniementie 2 (Bioteknia), Kuopio.
A GMP licence extension was applied for and it was granted. Laboratory services were supplemented with sterility and endotoxin testing.
Pharmaceutical development services were supplemented with investigational medicinal production. A GMP license extension was applied for and it was granted.
Microbiological laboratory facilities were expanded in Neulaniementie 2 (Bioteknia), Kuopio.
The successful completion of 20 years in Estonia was celebrated.
Acquisition of Medfiles by WDB Holdings was made which enhanced our potential to grow globally in cooperation with our sister companies (in Japan, USA, and India).
Collaboration with the newly launched CIOMS Working Group was established.
The successful completion of 30 years in Finland and 10 years in Baltics was celebrated.
Production, packaging and labeling of investigational medicines (IMP) started as new services. Medfiles’ Global collaboration and networks were developed and strengthened through our sister companies of WDB Group in Japan, USA and India. Sales office in Tokyo, Japan was opened.
And development continues…
The small company of a couple of people has grown over the years into a business of about 150 people. 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!