EAS Consulting Group, LLC. provides a full range of regulatory services for the dietary supplement industry.
From determining the safety of new dietary ingredients and preparing NDI notifications for FDA review, to registering foreign dietary supplement facilities with FDA, and serving as the U.S. Agent for the registered firm, to assisting firms with the GMP Compliance of your facilities and training your employees, our expert consultants can help your firm stay compliant with FDA regulations.
Allow EAS to assist your dietary supplement firm with:
- Develop Regulatory Strategies
- Structure/Function and Health Claims
- GRAS Submissions
- NDI Notifications
- Dietary Supplement Labeling
- Good Manufacturing Practice Training
- Facility Auditing
- Gap Analyses
- Mock-FDA Inspections
- Contractor Audits (Manufacturers, Packagers, Distributors and Laboratory)
- Quality System Development
- Standard Operating Procedure (SOP) Writing
- Establishment of Specifications
- Raw Material
- Finished Product
- Stability Program Development
- Quality Agreement Preparation
- Regulatory Remediation
- 483 Observation Response
- Warning Letter Response
- Consent Decrees
- Corrective and Preventative Action (CAPA) Plans and Implementation
- Expert Witness
EAS Consulting Group is proud to have some of the top experts in the field as part of our team of senior consultants. Click here to see some of their former positions at both FDA and in industry.
The FDA is increasing its enforcement against dietary supplement firms via 483s and warning letters. Click here to see a summary chart prepared by EAS of FY 2013 observations in 483 reports.