Clinical manufacturing services for investigational medicinal products (IMPs)

Clinical manufacturing services for investigational medicinal products (IMPs)

Medfiles manufactures investigational medicinal products (IMPs) for clinical trials under our GMP license and GMP certificate granted by the Finnish Medicines Agency Fimea. Our Class D clean room facilities are suitable for manufacturing non-sterile clinical trial materials for phase I to phase III clinical studies.

Our small-scale manufacturing service provides flexible and fluent options for clinical manufacturing. Our technology enables the manufacturing of the following pharmaceutical forms:

  • Tablets
  • Capsules with hard shell
  • Other solid dosage forms
  • Liquids
  • Over-encapsulation.

In addition to manufacture, our services cover packaging (primary and secondary packaging) and labelling of medicinal products.

The service package is always tailored to your needs. You can outsource your entire project or just parts of it to us:

  • Project management
  • Environmental health, and safety (EHS) assessment for APIs
  • Assessment and qualification of material suppliers
  • Acquisition of raw materials and packaging materials
  • Manufacturing, packaging and labelling services
  • Chemical and microbiological quality control
  • Batch release and certification
  • Delivery to clinical trial sites
  • Stability studies and shelf-life assessment
  • Full documentation package

OUR GMP LICENCE INCLUDES

  • Manufacture, primary and secondary packaging
  • Labelling
  • Chemical and microbiological quality control  testing
  • Batch certification
  • Import and the related quality control and batch certification

CLINICAL IMP MANUFACTURING EXPERIENCE

IMP services started in 2018 – over 70 batches of IMPs manufactured since

100 m2 of production facilities (EU class D)

STAFF: about 10 production experts supported by analytical team and quality assurance specialists

Clients

Our team serves businesses in the pharmaceutical sector in Europe. Client satisfaction and trust are of paramount importance to us.

Cooperation with Medfiles has been great. The response times are quick, and the staff is always ready to help. Our requests are always met – even within tight schedules – which we highly appreciate.
– A Finnish pharmaceutical manufacturer

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