Gibco Drug Master Files and Regulatory Support Files
Thermo Fisher Scientific has submitted Drug Master Files to the US Food & Drug Administration (FDA) for many products. Wherever you are in the world, contact our industry-leading regulatory experts to cross-reference a DMF or to provide access to Regulatory Support Files.
DMF Authorizations for submissions to Health Canada can be supported upon request with a 4 to 6 week submission period.
DMF Letter of Authorization (LOA)
As a Thermo Fisher Scientific customer using one of our Gibco products in a manufacturing process, you may request that we provide reference authorization to our Drug Master File(s) in support of a submission or filing that you have made to the FDA. To initiate the reference authorization of our DMF, you must submit a Letter of Authorization request to Thermo Fisher Scientific requesting that we provide a DMF Letter of Authorization to the respective FDA Center. Once we have your request, we will advise the FDA that a Thermo Fisher Scientific Drug Master File is relevant to its review and that the agency has our approval to make that DMF part of your submission.
All information contained in a Drug Master File is considered confidential to the holder. Neither the FDA nor other outside party may have access to or release the file without the holder's consent.
Regulatory Support Files (RSFs)
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.