Searching for Regulatory Support Files information? Find all needed info by using official links provided below.
https://www.gelifesciences.com/en/us/support/quality/regulatory-support
With a subscription to regulatory support documentation, you can access these documentation types: Regulatory Support Files (RSF) for BioProcess chromatography resins; Validation Guides for single-use products, such as Xcellerex systems, Cellbag bioreactors, as well as ReadyToProcess products and process-scale filters
https://www.gelifesciences.com/en/us/support/quality/regulatory-support/regulatory-support-documents
We offer Regulatory Support Files (RSF) for chromatography resins, Validation Guides for single-use products, Validation Support Files for software, and Extractables Summaries for certain BioProcess hardware. This documentation is available to you once you have created an account and signed the on-line confidentiality agreement.
https://www.thermofisher.com/us/en/home/life-science/bioproduction/bioproduction-resources/regulatory-support/cell-culture-drug-master-files.html
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 …
https://www.westpharma.com/support/regulatory-support
The mission of West Regulatory Affairs (RA) is to provide customers with industry leading support for their global regulatory needs. West RA, provides a single point of contact to assist with global registration strategies for all West products and processes.
https://www.thermofisher.com/us/en/home/life-science/bioproduction/regulatory-support.html
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 ...
https://www.lonza.com/custom-manufacturing/capabilities-overview/regulatory-support.aspx
Site Master Files have been registered for all relevant Lonza production sites. Lonza Custom Manufacturing has substantial experience in submitting type II DMF's to the U.S. FDA and E-DMF's to other national regulatory authorities in Europe, Canada and Australia among others.
https://ccrod.cancer.gov/confluence/download/attachments/73203825/CCR%20Regulatory%20File%20SOP%20031015%20final.pdf?version=1&modificationDate=1427462911057&api=v2
Step 1: Develop Regulatory Files for each study Regulatory files must be created for each study, both interventional and observational. The files will contain all the essential documents as listed in GCP Guidelines, ICH GCP E6 Section 8. Electronic files may be used in which case, the file outline and nomenclature established by the
https://lgmpharma.com/regulatory-support-services/
Regulatory Support Services Understanding our clients’ regulatory requirements, technical and commercial expectations is key to our business
https://www.emdmillipore.com/US/en/support/regulatory-support/Up.b.qB.CN8AAAFAnd8QWRbW,nav
Regulatory Support Active pharmaceutical ingredients, excipients and pharmaceutical raw materials are part of the challenge for our Regulatory Service department. To fulfill all of these requirements, we support the regulatory and quality related activities of the various business units.
https://www.uhhospitals.org/uh-research/research-and-clinical-trials/core-offices/regulatory-and-fda-support/fda-and-regulatory-support/
Oversee progress of the trial and ensure compliance through routine monitoring of regulatory documents, site files, and subject files. Provide support and assistance to all study sites and staff during the conduct of the study. Ensure all data is accurate and supported by …
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