What we do

Value chain

Development services

  • Literature search scoping (externally)
  • Preformulation studies (externally)
  • Formulation studies (patrially externally)
  • Process Development
  • Process optimization and scale-up
  • Stability (stress, preliminary)
  • Analytical method development/validation

API sourcing

  • Together with external partners

Clinical supply services

  • Technology transfer
  • Manufacturing on commercial line
  • Analytical testing
  • Stability (ICH, photostability, Zone IV, infusion, in-use, transportation, etc.), storage of retention samples
  • Freeze-thaw studies
  • Storage, Shipment, including cold chain management
  • Regulatory support (data provided, answers to the authorities) eCTD compilation (with external partners)
  • Certification of batch for Clinical Study

Commercial supply services

  • Technology transfer
  • Manufacturing on commercial line
  • Analytical testing
  • Stability (ICH, photostability, Zone IV, infusion, in-use, transportation, etc.), storage of retention samples
  • Freeze-thaw studies
  • Storage, Shipment, including cold chain management
  • Regulatory support (data provided, answers to the authorities) eCTD compilation (with external partners)
  • Batch certification to the customer and/or market

Analytical/microbiological services

  • Analytical methods transfer/validation
  • Product release testing
  • Cleaning methods development and validation
  • Stability (ICH, photostability, Zone IV, infusion, in-use, transportation, etc.), storage of retention samples
  • Raw materials testing in compliance with cGMP
  • Environmental monitoring
  • Bioburden, Bacterial Endotoxins (internally), Sterility (outsourced)
  • Batch certification to the customer and/or market

Packaging

  • Secondary packaging (labeling, box, carton)
  • Manual packaging (internally)
  • Automated packaging (externally)
  • Serialization (externally)
  • Storage, Shipment, including cold chain management
  • Batch certification to the customer and/or market