EAS Consulting Group, LLC. provides regulatory assistance to the food, dietary supplement, pharmaceutical, OTC, medical device, cosmetic and tobacco industries. Our vast network of professionals work directly with company’s in-house counsel, or on behalf of a company through outside counsel, EAS offers unparalleled technical support and expert guidance in all areas of FDA regulatory compliance.
EAS consultants have FDA and high level industry experience. Whether your firm is looking for an expert witness for clarification of FDA policies and procedures; assistance with the preparation of regulatory responses or submissions; GMP facility audits; or other client needs, EAS can be a strong and effective resource.
Examples of Support Areas to Law Firms:
- Warning Letter and Form FDA 483 Responses
- Due Diligence
- GRAS Notifications
- Food Contact Notifications
- New Dietary Ingredients (NDI), Pre-Market Approvals (PMA), Investigational Drug Exemption (IDE), Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Drug Master File (DMF), New Animal Drug Application (NADA)
- Novel Foods, Novel Food Ingredients, New Food Additives
- USDA Labeling Assistance
- Facility Registration and Product Listing
- Labeling and Claims
- Product Classification
- 510(k)s for Medical Devices
- Adverse Event Reporting and Tracking
- Recall Management Plans and Executions
- Food ingredients and additives, functional foods
EAS Consulting Group, LLC, has provided thousands of hours in expert witness preparations and testimony for federal and state court lawsuits. Our expert consultants, former FDA officials and high level industry leaders, draw on their experience at and with FDA, as well as the regulatory process to provide expert opinion on FDA policies and procedures. This opinion helps companies prepare and defend against suits regarding health claims, structure/function claims, product and production safety, manufacturing, and many others.