Regulatory Documentation

For all commercially manufactured active pharmaceutical ingredients PharmaZell holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities in the US, Europe, Japan, Canada and Australia.

This extensive experience in Regulatory Affairs over many years in combination with PZ’s process development expertise can carry customer’s projects fast all the way till successful product launch.

Concurrently during the development process stages relevant data for Chemistry, Manufacturing & Control (CMC) documentation are compiled and prepared for filing. Regulatory assistance is given in all aspects of customer product including meeting with regulatory agencies to discuss manufacturing and testing issues.

The registration dossiers are maintained in close cooperation with the customer during the life-cycle of a product.

PharmaZell's sites are regularly audited by competent authorities.