Many of Thermo 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.


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.

FDA registration numbers

 
  • Grand Island, NY, USA - 1317268
  • Paisley, Scotland - 8040470

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

Email: LSG.Regulatory@thermofisher.com

BioProduction resources

Click below to access products brochures, training videos, mobile apps, and more.

Support

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