EAS Consulting Group – Your Source for GMP Regulatory Compliance Solutions
Adherence to the FDA’s Dietary Supplement Good Manufacturing Practices (GMPs) can make or break a business.
GMPs, as dictated in 21 CFR 111, are mandated requirements that will ensure that dietary supplement products are consistently manufactured to established specifications for quality. In 16 Subparts, pertaining to everything from personnel and dietary supplement production process controls to holding, distribution and handling customer complaints, the basic tenants of how GMPs should be executed are mapped out. Yet, developing and implementing GMP compliant systems continues to challenge the dietary supplement industry.
EAS Consulting Group, leaders in FDA regulatory compliance strategies, provides a solutions-based approach to GMP challenges. EAS provides on-site facility gap-analyses to determine necessary corrective and preventative actions (CAPAs) and then can assist with those CAPAs. Personnel training on GMPs can also be performed in-house or via our highly regarded public GMP training seminars, complimentary live webinars, and on-demand webinars. EAS offers the answers you need to keep your business in compliance. Join us at one of our upcoming programs, or contact us to learn how we may provide dedicated assistance as your GMP regulatory consultant.
About EAS Consulting Group, LLC
EAS Consulting Group continues 55 plus years of leadership in providing regulatory consulting to the industries regulated by the FDA and other federal and state agencies. Our network of independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services to the dietary supplement, pharmaceutical, food, medical device, tobacco, and cosmetic industries. Whether the need is assistance with general FDA or USDA regulatory compliance or more specific needs such as product development, New Dietary Ingredient submissions, FSMA regulation compliance, generic or customized compliance trainings, 483 responses, product-market withdrawals or recalls, mock-FDA audits, expert witness services, GRAS & food additive issues, dietary supplement labeling compliance or the development of a detailed import strategy and policy, EAS, with its over 150 consultants, former FDA compliance officials, and industry experts, is able to assist. With vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance in FDA and other regulatory matters. easconsultinggroup.com
EAS Consulting Group, LLC
1700 Diagonal Road, Suite 750, Alexandria, VA 22314
(877) 327-9808 Toll-Free • (571) 447-5500 Local • (703) 548-3270 Fax