Transfer of commercial scale processes


All UQUIFA's sites operate under cGMP conditions and have been inspected and approved by the FDA, EDQM, ANVISA and/or KFDA.

In addition to the regular production programs, Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity characterisation.

  • Process transfer
  • Process development and improvement
  • Analytical methods development
  • Scale up to commercial
  • Reference standards synthesis
  • Impurity profile characterisation
  • Stability Studies
  • Polymorphism Studies
  • Regulatory support and file submission and maintenance