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Regulatory Consulting Services from EAS Consulting Group, LLC


General Information
Product Regulatory Consulting Services
Company EAS Consulting Group, LLC
Area of Expertise: Full range of regulatory consulting services to the food and dietary supplement industries including GRAS, NDI, and FCS notifications, food safety consulting, HACCP, GAP, GMP, LACF audits, label compliance reviews, structure/function claims.
Description

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 is assisted by an extensive network of consultants with many years of FDA and industry experience.

Food/dietary supplement consulting, submission, and auditing services including:

Foods

  • Reviewing labels and advertising for compliance with regulations.
  • Determining the safety of food ingredient and preparing food additive petitions, GRAS reviews and notifications, food contact substance notifications, and risk assessments.
  • Designing clinical studies to substantiate label claims.
  • Preparing petitions for FDA approval of conventional and qualified health claims for food and new dietary ingredients.
  • Serving as expert witnesses and providing testimony on litigation involving disputes over regulatory food matters.
  • Providing technical assistance to acidified and low acid canned food manufacturers, and assisting in registering their facilities and processes with FDA.
  • Interpretation of rulings and policies of FDA, USDA, EPA, and other agencies as they relate to products or practices.
  • Registering foreign food facilities with FDA and serving as the U.S. Agent for the registered firm.
  • Providing guidance on import procedures and assisting in obtaining clearance of products through U.S. Customs and FDA at time of entry.
  • Assisting firms implement food security measures to prepare for deliberate acts of terrorism
  • Providing recall advice and assistance as needed.
  • Conducting warehouse sanitation, GAP, GMP, and HACCP audits.

Dietary Supplements

  • Providing consulting assistance on GMP compliance and conducting GMP audits.
  • Reviewing laboratories for compliance with GMP requirements.
  • Reviewing dietary supplement labels/advertising for compliance with regulations.
  • Evaluating structure/function claims and preparing 30-day notifications for submission to FDA.
  • Determining the safety of new dietary ingredients and preparing NDI notifications for FDA review.
  • Designing clinical studies to substantiate product label claims.
  • Reviewing the scientific literature and preparing petitions for FDA approval of conventional and qualified health claims for dietary supplement ingredients.
  • Interpretation of rulings and policies of FDA and other agencies as they relate to products or practices.
  • Registering foreign dietary supplement facilities with FDA, and serving as the U.S. Agent for the registered firm.
  • Providing guidance on import procedures, and assisting in obtaining clearance of products through U.S. Customs and FDA at time of entry.
  • Assisting firms implement security measures to prepare for deliberate acts of terrorism.
  • Providing recall advice and assistance as needed.


EAS Consulting Group, LLC Contact Information

EAS Consulting Group, LLC

1700 Diagonal Road, Suite 750
Alexandria, VA 22314

Phone Number: (571) 447-5500
esteele@easconsultinggroup.com

EAS Consulting Group, LLC Web Site

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