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