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https://www.westpharma.com/support/regulatory-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/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.
https://www.who.int/medicines/areas/quality_safety/regulation_legislation/en/
Medicines regulatory support Effective medicines regulation promotes and protects public health by ensuring that: medicines are of the required quality, safety and efficacy;
https://www.urmc.rochester.edu/clinical-translational-science-institute/clinical-research/regulatory-support/investigational-drugs.aspx
Investigational Drugs The Office of Regulatory Support (ORS) provides a variety of services to support development of Investigational New Drug (IND) application submission, and provides guidance and assistance throughout the life cycle of IND-regulated studies.
https://www.fda.gov/drugs/regulatory-science-research-and-education/developing-real-world-data-and-evidence-support-regulatory-decision-making-10032019-10032019
This is a meeting webpage announcing a conference on Developing Real-World Data and Evidence to Support Regulatory Decision-Making. This conference will bring together experts to examine topics in ...
https://www.freyrsolutions.com/drugs-regulatory-intelligence
Drug labeling translations, Regulatory Intelligence, Support, Generics Freyr provides regulatory Intelligence services to global pharmaceutical and biopharmaceutical companies that spans across addressing regulatory query, Drug labeling translations & support and product registration.
https://www.sciencedirect.com/topics/medicine-and-dentistry/regulatory-affairs
Jan 01, 2004 · I Hägglöf, Å Holmgren, in Drug Discovery and Development (Second Edition), 2013. The role of the regulatory affairs department. The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market.
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