Regulatory Affairs and Support

PENTAPHARM's well-established SOP system and their up-to-date GMP trained staff ensure GMP compliance. Our facilities include class 100 clean rooms and large-scale lyophilization capacities. PENTAPHARM's FDA-inspected production facilities provide the structure for large-scale isolation and purification of API's, such as Aprotinin and Hemocoagulase.

PENTAPHARM offers a wide range of services:

  • Process validation
  • Validation of analytical methods
  • Stability studies
  • Process documentation
  • Preparation of drug master files
  • Filing of patent application