Many of Thermo Fisher Scientific's products are used as raw materials by global biopharmaceutical companies for further manufacturing applications, so we are ready to support your regulatory needs.
For many of our cell culture media products we have Drug Master Files (DMFs) submitted to the US Food and Drug Administration (FDA).
The DMF may be used to provide confidential information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of certain products. This information may be used to support an Investigational New Drug (IND) applications, Biological License Application (BLA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA) or another DMF.
Please note that cross reference by the FDA is only possible in combination with an IND, BLA, NDA or ANDA application.
For regulatory documentation support for regions outside of the USA please refer to our Regulatory Support Files below.
For regions without an equivalent DMF mechanism for raw materials used in further manufacturing, we can provide access to confidential Regulatory Support Files (RSFs) for products used in regulated environments. The information in these files includes detailed information on product performance, stability, quality control and analytical testing methods. As opposed to DMFs, an RSF is made available for customer review. The information within the RSF can be used to support clinical and marketing applications to regulatory agencies.
Please note, an RSF is available only after signing a confidentiality agreement, as some of the information is proprietary.
Submit a request to have Thermo Fisher Scientific provide either a Letter of Authorization or a Regulatory Support File