Formulation development
Our clean room production facilities are suitable for manufacturing small-scale non-sterile liquids and solid dosage forms as well as for early formulation work for sterile products.
- Veterinary and human drug products
- Generic drug/medicinal products
- R&D experience in several dosage forms:
solutions, suspensions, powders, granules, tablets, hard capsules, ointments, creams, sterile products
- Development and validation of analytical methods
- Food supplements
Production of non-sterile IMPs
Medfiles has GMP licence to manufacture Investigational Medicinal Products (IMPs) for clinical trials of our clients.
- Manufacturing of IMPs in following dosage forms:
- Capsules, hard shell
- Liquids for external or internal use
- Other solid dosage forms
- Intermediates: liquids and powders for further processing
- Primary packaging for following dosage forms:
- Capsules, hard and soft shell
- Liquids for external and internal use
- Other solid dosage forms
- Tablets
- Other non-sterile medicinal products
- Secondary packing for all dosage forms
- Over-encapsulation
- Labelling
- QP certification for clinical trials
- Comprehensive clinical study services
Premises and equipment
- Product development laboratory
- Processing equipment for solids, solutions, suspensions and semi-solids
- GMP production area
- Class D
- Two manufacturing booths and utility areas, total area of about 80 m²
- Equipment for solid material processing
Stability study services
- Featuring studies under long-term and accelerated conditions according to current ICH/VICH guidelines as well as on-going stability studies
- Customised testing (e.g. shipping, in-use studies and other stress testing)
- Photostability testing
- Implementation of guidelines and standard operation procedures for stability study policies
- Managing and coordination
- Training in stability study related topics
- Storage capasity of qualified stability chambers and walk-in storage rooms
- Continuous temperature and humidity monitoring and 24/7 remote control
Technology transfer, industrialisation and product maintenance
- Technology transfer plans and supportive actions in execution
- Manufacturing process development, optimisation and validation
- Analytical method transfers and process validation analytics
- Project management
- Problem-solving
- Reporting
- Supply chain support / Product maintenance
- Pharmaceutical documentation
- Regulatory affairs
- Clinical services
