Next Upcoming Webinar: Unraveling The Impact of FSMA On Acidified Food Regulations – December 7, 2017

Specializing in FDA Regulatory Matters

Regulatory Support for Law Firms

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; assist 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:

  • Expert Witness
  • Remediation, Warning Letters, and 483 Responses
  • Due Diligence
  • Label and Claim Review
  • GRAS and Food Contact Notifications
  • New Dietary Ingredients (NDI)
  • Pre-Market Approvals (PMA), Investigational Device Exemption (IDE), Investigational New Drug (IND), New Drug Application (NDA), Drug Master File (DMF) and more
  • Novel Foods, Novel Food Ingredients, New Food Additives
  • Labeling Advertising Assistance
  • Facility and Product Registration and Listing
  • Consent Decrees Remediation
  • Import and Export Assistance
  • Product Classification
  • Adverse Event Reporting Assistance and Tracking
  • Recall Management Plans and Executions

 

Expert Witness

EAS has provided thousands of hours in expert witness preparations and testimony for each of the FDA regulated industries. Our expert consultants, former FDA officials and high-level industry leaders, draw on their professional experience to provide expert opinions on FDA requirements, policies, and procedures. Their opinions help companies prepare for and defend against lawsuits regarding health and medical claims, structure/function claims, product safety and efficacy, manufacturing procedures, and many others.

Remediation and Consent Decrees

In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.

Our experts are former FDA inspectors with strong regulatory backgrounds, specially trained in FDA regulations. For example, our seafood auditors are experts in the principles of Hazard Analysis and Critical Control Point (HACCP), and our drug and dietary supplement auditors are experts in understanding the applicable regulatory requirements. EAS auditors are available to conduct facility audits throughout the drug, medical device, food, dietary supplement, tobacco, and cosmetic industries.

Submissions

Our team of drug and device experts, toxicologists, food scientists, and medical experts is available to guide you through the complex regulatory process. By seeking our advice early, we can outline the quickest, least expensive route to satisfy the applicable marketing requirements. Our scientific staff is internationally known for their expertise in conducting safety reviews and in gaining approvals from FDA and other regulatory bodies. We will review your client’s situation and make recommendations on the available options. We will map out a strategy for compiling the necessary data and, where necessary, submit a letter, GRAS, FCN or NDI notification, NDA, DMF or other data package to the FDA. We are available to convene expert panels to conduct an independent safety evaluation of a food, color, or dietary ingredient when needed.

Due Diligence

EAS is staffed with former FDA investigators and industry auditors that are available to audit firms that your clients are either considering purchasing or have an interest in having contract work performed by. Before they invest in such a firm, EAS can assess their current level of compliance with FDA Good Manufacturing Practice regulations and identify what it will take to bring these facilities into compliance. By having EAS on their due diligence team, costly mistakes can often be avoided.