Contact us

Sartorius CellGenix GmbH
Am Flughafen 16
79108 Freiburg
Germany
fax: +49 761 888 89-830
ADDRESS SARTORIUS CELLGENIX HQ & OFFICES
Sartorius CellGenix GmbH
Am Flughafen 16
79108 Freiburg
Germany
fax: +49 761 888 89-830
CellGenix Inc.
One New Hampshire Avenue, Suite 125
Portsmouth, New Hampshire 03801
USA
 
HOW TO ORDER

Please be aware that in North America and EMEA (except Italy and Israel) all CellGenix® products are now sold directly via Sartorius.

You can purchase our products via the Sartorius eShop or by sending your purchase order to:

Orders Italy, Israel, APAC, and rest of the world: find your local contact here

CUSTOMER SERVICE & TECHNICAL SUPPORT

We understand that high quality products go hand in hand with outstanding service.
Our knowledgeable team is always happy to assist you with any requests and/or questions you may have.

You can find our Certificates of Analysis, Data Sheets, MSDS, Technotes and Application Notes under Resources.

Customer Service
phone: +49 761 888 89-330
fax: +49 761 888 89-830
email: customerservice@cellgenix.com

Customer Service USA & Canada
phone: +1 800 368 7178
email: techsupport@sartorius-stedim.com

REGULATORY SUPPORT

In order to obtain a market authorization for your ATMP it is crucial that you can rely on your GMP grade raw materials to be compliant with international guidelines and local requirements. We assist you with your approval process by offering:

  • Expert technical and regulatory support on raw materials
  • Possibility to audit our production site
  • Drug Master Files for cross-reference
  • Change notifications prior to relevant changes (with or w/o QM agreement)
  • On-demand customized documentation for regional authorities

You can find our Certificates of Analysis under Resources. Regulatory Support Files and TSE certificates are available on request.

Please contact our Regulatory Support Team for all your regulatory requests & questions:

Regulatory Support Team
phone: +49 761 888 89-0
email: regulatorysupport@cellgenix.com

DMF LETTER OF AUTHORIZATION

USA

The FDA can access our Drug Master Files (DMF) in conjunction with a letter of authorization. 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.

JAPAN

The PDMA Master File is available for CellGenix® GMP SCGM.

Please provide your company name, name of the contact person and name of the drug Marketing Authorization.

More information about our DMF Service

Contact our Regulatory Support Team to request of authorization to cross-reference our DMF.

CHANGE NOTIFICATIONS

All relevant GMP product changes are communicated well in advance through our change notifications. This enables you to put the necessary preparations in place without causing delays in your production process.

You can register here if you would like receive our change notifications