Regulatory Services
For all commercially manufactured products 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 for all active pharmaceutical ingredients.
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•Presentation: PharmaZell Overview
For all commercially manufactured products 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 for all active pharmaceutical ingredients.
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. This includes adaption of dossiers to state of the art technologies.
These documents are prepared during product development, submitted to the authorities, maintained and updated during the life cycle of the products. PharmaZell's sites are regularly audited by competent authorities.
Click Here To Download:
•Presentation: PharmaZell Overview