Getting a clear understanding of regulatory requirements around the quality of raw materials can be challenging. There is currently no global harmonization and existing guidelines can be interpreted in different ways.

We are actively involved in many of the regulatory initiatives and discussions and have more than 25 years of experience in the development and GMP manufacturing of cell and gene therapy products. This unique background allows us to offer you expert regulatory support and assist you with your regulatory approval process.

Regulatory Support

We can assist you with your regulatory approval process by providing expert regulatory support:

• Auditing of our production site upon request

• Drug Master Files for cross-reference (USA & Japan only)

• Regulatory Support Files, TSE Certificates (upon request)

• Change notifications prior to relevant changes (with or w/o QM agreement)

• On-demand customized documentation for regional authorities 


Contact our Regulatory Support Team for all your regulatory requests & questions

Phone:     +49 761 88 88 9-0

Drug Master Files

A Drug Master File (DMF) is a regulatory instrument that provides confidential detailed information about the product safety, manufacturing conditions and analytical aspects. Ancillary Material (AM) manufacturers can submit this document to the authorities. It enables the AM manufacturer to protect its intellectual property by allowing the authority to review the information in support of a third party’s regulatory submission (eg. IND or BLA).


We have submitted Drug Master Files (DMF) to the US Food and Drug Administration (FDA) CBER for most of our GMP grade products to support our US customers’ submissions to the FDA.

The DMF contains confidential information on a product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging. This information may be used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug application (NDA) or Abbreviated New Drug Application (ANDA), another DMF, an export application or amendments to any of these.

Please note that cross reference by the FDA is only possible in combination with an IND, BLA, NDA or ANDA application. To date, no comparable DMF System for biological raw materials is in place in Europe.

Sartorius CellGenix DMFs are Type II DMFs which are submitted in Electronic Common Technical Document (eCTD) format.

Reference Authorization
The FDA only has access to a DMF in conjunction with a letter of authorization that permits the FDA to reference the DMF. You can initiate a cross reference authorization for a Sartorius CellGenix DMF by submitting a letter of authorization request. After receiving your request, we will inform the FDA that they have our approval to include the Sartorius CellGenix DMF in your FDA submission.

We currently offer DMFs for the following products:


We have submitted a Drug Master File (DMF) to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for our CellGenix® GMP SCGM to support our customers’ submissions to the PMDA.

This Master File can be cross-referenced in Marketing Authorizations submitted to the Japan PMDA and will be reviewed in conjunction with the Marketing Authorization evaluation. 

to request of authorization to cross-reference our DMF.

Please provide:

  • your company name
  • name of the contact person in your organization
  • name of the drug Marketing Authorization

We currently offer one DMF for the following product:

Serum-free Media

CellGenix® GMP SCGM