Many of Themo Fisher Scientific's products are used by biopharmaceutical companies around the world for further cell culture manufacturing, so we are ready to support your regulatory needs.

If you need additional information or have any questions, please contact Regulatory Affairs or your Bioproduction Specialist for assistance regulatory Affairs or your Bioproduction Specialist for assistance.


Search Drug Master Files (DMF)

Search Thermo Fisher Scientific's DMF records to find out whether a DMF has been submitted for a particular product.

Request An Authorization Letter

If your product is found in the DMF search, submit a request to have Thermo Fisher Scientific provide the FDA with an authorization letter to view our DMF.

ISO Certifications

FDA Registration Numbers

 
  • Grand Island, NY, USA - 1317268
  • Paisley, Scotland - 8040470
  • New Zealand - 1317268
  • Australia - 3005606416

USDA Information

 
  • Grand Island is inspected by the USDA bi-annually for compliance with importation of raw serum under Veterinary Services Notice 98-05. 
  • Import animal products under USDA import permits.
  • EC 1774 Inspection numbers: NY-TEC-0001 for exporting of Mexican and US origin FBS to the EU under European Regulation EC 1774/2002.

Contact Regulatory Affairs

Call Kelli Tanzella, Ph.D. (Senior Manager, Global Regulatory Affairs) at 1-716-774-3122 or email kelli.tanzella@lifetech.com