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Urgent Message to all Supplements , Dietary Products, Vitamins manufacturer or distributor?

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Meet Roberto Correa-LEC Global Quality Consultant

Eng. Roberto Correa Lead Consultant, Global Regulatory Affairs and Quality Assurance Lean Enterprise Consulting Eng. Correa is a Florida, USA – based global consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and...

FDA Regulations Seminar- Better Safe than Sorry!

You and your team are invited on Thursday, December 12, the SFMA’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be? (Register now) Looking forward to seeing you there to share our knowledge and regulatory concerns...

Transdermal and topical delivery systems – NDAs and ANDAs

FDA announced today the availability of draft guidance for industry entitled “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations.” This guidance provides recommendations to applicants and manufacturers of transdermal...

FDA Final Guidance on Certificate to Foreign Government (CFG)/ Medical Devices

  Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices to explain why the FDA may deny issuing a Certificate to Foreign Government (CFG)...
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