EAS Expands GRAS Capabilities with Toxicology, CRO Services
ALEXANDRIA, Va., April 8, 2019 /PRNewswire/ -- EAS Consulting Group, LLC, leaders in FDA regulatory consulting services is pleased to announce the expansion of capabilities and comprehensive services offered to clients seeking to file a Generally Recognized as Safe (GRAS) and other submissions documenting food safety to the U.S. Food and Drug Administration (FDA).
As part of the safety documentation, companies seeking to petition FDA's recognition of a new food ingredient must submit data proving the ingredient in review is safe when prepared and used under conditions commensurate with those of the sponsor or petitioning organization.
In some cases, previous publicly available studies may be utilized. But in others, new studies must be designed, a Contract Research Organization (CRO) must be identified, and the study must have strict oversight by a dedicated team of toxicologists and microbiologists who review protocols and study progress to ensure validation and verification.
EAS, with our over 150 independent consultants, experts in their fields, pleased to provide expanded services for those firms seeking to demonstrate food safety, both through GRAS or Independent Self-GRAS filing. Our experts help with developing study designs and protocols to properly and accurately demonstrate performance criteria, assist with the identification of an appropriate CRO, coordinate study initiation and management with the CRO as well as provide on-going monitoring of study protocols and outcomes.
These expanded services are in addition to the GRAS and toxicology services for which EAS is well known, such as pre-meetings with FDA, performing initial feasibility studies, identification of appropriate data to support study reports and dossier preparation and submission.
Should your company be in the market research phase of a new or reformulated product that requires GRAS, including the development of a New Infant Formula, contact EAS Consulting Group to learn more about our services and how we may support your efforts. You may view GRAS information our website, review our GRAS services sheet or contact Cathryn Sacra directly at [email protected] or 571-447-5505.
About EAS Consulting Group:
EAS Consulting Group continues 55 plus years of leadership in providing regulatory consulting to the industries regulated by 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
SOURCE EAS Consulting Group, LLC
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