The Experts in FDA Regulatory Matters
EAS Consulting Group is a leading provider of regulatory compliance solutions to industries regulated by FDA, USDA, and supporting agencies. Our team of consultants provide expert guidance for all of your regulatory requirements.
LEARN MORE
LEARN MORE
LEARN MORE
LEARN MORE
Learn With Us
Seminars
Preparing for an FDA CTP PMTA Pre-Approval Inspection
Join EAS Consulting Group’s Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. and EAS Independent Consultant, Charlotte Peyton, for a comprehensive look at preparing for FDA’s PMTA pre-approval inspections. July 14, 2021 from 12pm-4pm eastern.
Webinars
Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation
Presented by EAS Independent Consultant, Carlos Ortiz July 15, 2021, 1:00pm easternDid you know that FSMA requires an established FSVP that places the onus of compliance verification for all aspects of FSMA on the importers? Failure to meet FSVP requirements can...
On Demand Webinars
“Own Label” and “Private Label” Distributor Responsibilities
A complimentary EAS Consulting Group webinar Presented by Bruce ElsnerIf you are an “Own Label Distributor” (OLD) or “Private Label Distributor” (PLD) it is imperative that you understand FDA compliance expectations. With more and more of the OTC drug and dietary...
COVID-19 Updates
Food Industry Control and Protection Against COVID-19
The COVID 19 Pandemic has forced the food industry to alter some of its operations in order to maintain a safe environment for its employees and customers. Urgent attention must be given to ensure compliance with measures that protect food workers from …
EAS Update: FDA Announces Resumption of Domestic Inspections with New Risk Assessment System
FDA announced on July 10, 2020 its intention to resume prioritized domestic inspections beginning the week of July 20, 2020. The locations of inspections will be based on the COVID-19 virus’...
Food Labeling Challenges in a Pandemic
Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent …
Latest News
Drug and Device Corner April 2021
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been...
Remote Interactive Evaluations – FDA’s New Tool for Drug Facilities… And Beyond?
Amy Scanlin, M.S. In April 2021 FDA issued Final Guidance for Industry concerning Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19...
“Own Label” and “Private Label” Distributor Responsibilities
A complimentary EAS Consulting Group webinar Presented by Bruce ElsnerIf you are an “Own Label Distributor” (OLD) or “Private Label Distributor” (PLD) it is imperative that you understand FDA...
Get the Newsletter
Subscribe to EASeNews and join the nearly 20,000 who receive the monthly EASeNews regulatory newsletter.
EAS – Your Dedicated Consultant for FSVP Services
EAS offers comprehensive services related to FSMA’s FSVP program for both foods and dietary supplements. We can even act as your Qualified Individual. For more information about our services, watch our short video.
Dietary Supplement Good Manufacturing Practice Compliance Short Course
The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters for a failure to comply with even the basic tenets of the regulation. EAS Consulting Group’s two-part short course covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of SOPs, and Good Documentation Practices (GDPs). It also addresses the top 5 observations cited in FDA Warning Letters since 2010 which are Specifications, Master Manufacturing and Batch Production Records, Quality Unit responsibilities, Product Complaints, and Holding and Distribution Operations.
Got a Question?
Contact Us Today for a Complimentary Consultation!