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
    • Other solid dosage forms
    • Liquids for external or internal use
    • 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