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.
Medfiles started collaboration with its US-based sister company. Also other international activities were developed further.
Investments in R&D and IMP services were continued to strengthen the Medfiles service portfolio.
Investments were also made in the non-drugs sector (food and nutrition, medical devices) in order to reinforce the company’s position on the interface of medicinal and non-drug products.
The Helsinki office space in Vantaa was expanded.
Despite the COVID-19 pandemic and its profound impact on the entire world, 2020 was a good year for Medfiles. Many new deals were closed and attractive revenues generated by serving our clients in the best possible way. Let us have a closer look at the past year:
- In May 2020, Gregory Ambra was appointed as the new CEO of Medfiles Ltd.
- Ninokata Norifumi was nominated as the new President.
- A new Cyber Security Incident Response Team (CSIRT) was established by the IT department in order to better respond to new cyber security challenges.
Clinical study services
- Medfiles and its sister company DZS Clinical Services reinforced their mutual collaboration and initiated several joint projects.
- A set of new SOPs was compiled to ensure conformity with the MDR regulation and the updated ISO 14155 standard.
- A new Agatha eTMF system was taken in use in the EU area.
- QP certification service was activated.
- Medfiles passed Fimea’s GMP inspection successfully with no major or critical findings.
- Data integrity compliance was improved with new systems and equipment.
- New technology in the form of a rotary benchtop tablet press was introduced to strengthen R&D and laboratory operations.
- In the RA pharma unit, data management in client projects was further enhanced and a GMP auditrelated training started in 2020 in order to prepare for the new audit service to be launched by the end of 2021.
- Several external trainings were organised by MD and IVD services.
- Food unit helped their clients in several novel food projects.
- Regulatory services related to feed and cosmetics were added to the Food unit’s service portfolio.
- The PV team was reinforced with new employees and the EU QPPV services were improved by introducing new resources.
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!