Product development and production of IMPs

We have experience in pharmaceutical product development for over 15 years. We provide comprehensive services in product development from early clinical phases to marketing authorisation, for both human and veterinary products. Our GMP licence covers also to manufacturing of Investigational Medicinal Products (IMPs) for clinical trials. We perform stability studies according to the ICH/VICH guidelines and additional tailor-made studies as per clients’ needs. Technology transfer and industrialisation services are an essential part of the complete service package offered by us.  

Formulation development

  • Veterinary and human drug products
    • • Products for early clinical phases
    • • 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

 

Premises and equipment

  • Product development laboratory
  • GMP production area
    • • Class D
    • • Two manufacturing booths and utility areas, total area of about 80 m2
  • Equipment for solid material processing
  • Equipment for solutions, suspensions and semi-solids

Stability studies

  • Services
    • • Featuring studies under long-term and accelerated conditions
      according to current ICH/VICH guidelines
    • • Customised testing (e.g. shipping and in-use studies)
    • • On-going stability testing for products on the market
    • • Stress testing 
    • • Implementation of guidelines and standard operation procedures for stability study policies
    • • Management and coordination: study protocols, scheduling, testing,
      stability data handling and reporting
    • • Training in stability study related topics

  • Facilities
    • • Stability chambers for several standard conditions according to the ICH/VICH guidelines
    • • Possibility to tailor-made storage conditions
    • • Storage capacity include:
      • • Qualified stability chambers
      • • Walk-in storage rooms
    • • Continuous temperature and humidity monitoring and 24/7 remote control

Technology transfer and industrialisation

  • Technology transfer plans and supportive actions in execution
  • Manufacturing process development, qualification and validation
  • Analytical method transfers and process validation analytics
  • Project management
  • Problem-solving
  • Reporting
  • Supply chain support / Product maintenance

For more information please contact

Laboratory manager Minna Johanna Heiskanen