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FDA

Food & Drug Administration: www.fda.gov

FDA’s site provides a wealth of information related to all FDA regulations, FDA Inspectional Techniques, registering your establishment, conducting a recall, Warning Letters Issued and much more.

     
FDA

FDA Small Manufacturers and Foreign Manufacturer Support Page: www.fda.gov/cdrh/industry/support/

As a smaller company or a foreign company trying to understand what is required to comply with FDA requirements, this is a very helpful site. The site gives you the “How to” handle everything from marketing a new product, to handling an FDA Inspection, to conducting a recall for violative product.

     
International Standards Organization

International Standards Organization: www.iso.org

Marketing your product in EMEA and the ROW requires meeting the ISO Standards. This site provides all the ISO documents and offers the ISO Standards (must be purchased) to build your library of Standards and understand which apply to you.

     
Regulatory Affairs Professional Society

Regulatory Affairs Professional Society: www.raps.org

RAPS is a critical networking, professional development and information source for regulatory affairs professionals and companies that desire to stay abreast of the every changing regulatory environment. One of the best places to go to keep your finger on the regulatory pulse of the world.

     
American Society for Quality

American Society for Quality: www.asq.org

Understanding product quality metrics and supportive quality activities (such as Internal Audits, External Audits and Supplier Audits) is challenging. ASQ provides education in these areas including certification programs to quality professionals seeking to demonstrate meeting various industry standards for their quality area of expertise or quality position within a company.

Want more? Send us an email at msherwood@zero483.com, tell us what information you are looking for and we’ll be happy to help locate websites that may help you!

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