Regulatory Support

Safety and Superior Quality: GMP Conditions and ADCF Policy

CellGenix has taken the lead to provide customers with high-quality GMP reagents which are suitable, safe, and reliable to be used as ancillary materials in clinical ex vivo cell culture.

For many years CellGenix has developed and manufactured products according to GMP guidelines and under ADCF conditions. We have filed DMF for many of our products at the FDA and other major regulatory authorities. Conformance with the new USP <92> standard supports our high quality claims.





We are committed to the satisfaction and success of our customers. Our customers benefit from our long-term experience as a GMP manufacturer of cell and recombinant protein therapeutics.

We provide expert regulatory and technical support and are pleased to help to optimize and advance your research and development efforts. Our specialized field service team is dedicated to fulfill your need and to provide high quality assistance.

As part of our service all customers will be given due notice about any product changes.

 

Documentation & Reference

Several regulatory documents can be found under Downloads

BPI Article "Standards for Ancillary Materials Used in Cell- and Tissue-Based Therapies" by Fouad Atouf, Nicole M. Provost, Felicia M. Rosenthal (CEO CellGenix)

Material safety data sheets can be obtained on request at our Regulatory Affairs Office.

Inquiries

For inquires please contact our Regulatory Affairs Office:

Regulatory Affairs & Quality Manager: Dr. Dagmar Blöcker

CellGenix GmbH
Am Flughafen 16
D-79108 Freiburg
Germany

Phone: +49 761 88 88 9 - 302
Fax:     +49 761 88 88 9 - 800
Email:   regulatorysupport@cellgenix.com