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.

Laboratory services

• 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.

Regulatory affairs

• Data management of the client projects was further enhanced.
• Several external trainings were organised by MD and IVD team.
• 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.

Contact our experts directly for business collaboration or write to contactus@medfiles.eu for service-specific queries.

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