Eurofins BPT Finland 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
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