Most people who work in the pharmaceutical industry know that drug development comprises of pharmaceutical development, animal pharmacology and toxicology studies, and clinical research; many also know that there are quality standards applied to manufacturing and controls that become more and more stringent as the development process evolves. Similarly, the quality standards for animal pharmacology… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout the U.S., Europe and Asia, EAS Consulting Group is a sought after expert in regulatory matters, assisting firms with highly technical submissions from GRAS, DMF, NDI, ANDA, 510(k) and others, to label reviews, structure function claims, GMP audits, US Agent assistance and to serve as expert witnesses. EAS consultants are routinely asked to speak at worldwide events on regulatory issues and is EAS is proud to have a solid reputation in the industry as the leading consulting and training firm for FDA regulatory matters.
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FDA released the much anticipated final rules for Produce Safety Foreign Supplier Verification Accredited Third Party Certification Firms can now begin the diligent and precise work of gap analysis and compliance planning to ensure all procedures are updated to meet FDA’s much stricter standards. The rules are a heavy read in their entirety so FDA… Read More
With FDA inspections becoming more frequent, particularly in the dietary supplement world, it is imperative that companies familiarize themselves with how to host and manage such an inspection. We say “manage an FDA inspection” because the more knowledge a company has the better able it will be to make the inspection process move smoothly in… Read More
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. The final FSMA rules are available in pre-published form - FSMA Final Rules. The Food and Drug Administration (FDA or we) is amending our regulation for Current Good Manufacturing Practice… Read More