Formulation development
Our product development laboratory is ideal 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. Our clean room facilities (class D) are suitable for manufacturing clinical trial material for phase I to III.
- Manufacturing and primary packaging of IMPs in the following dosage forms:
- Tablets
- Capsules, hard shell
- Liquids for external or internal use
- Other solid dosage forms
- Intermediates: liquids and powders for further processing
- Secondary packing for all dosage forms
- Over-encapsulation
- Labelling
- QP certification for clinical trials
- Comprehensive clinical study services
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
- Management and coordination
- Training in stability study related topics
- Storage capacity 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
