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Services

 

Consulting, Submission, and Auditing Services

The EAS Consulting Group (EAS) consists of experts who know what FDA and other regulatory bodies require of pharmaceuticals, medical devices, foods, dietary supplements, cosmetics, and other regulated products offered for sale in the United States or other countries throughout the world. Whether your company is large or small, domestic or foreign, we have the expertise to address your regulatory needs.

Many of our consultants are former FDA compliance officials, and several of our consultants played key roles in writing the U.S. food regulations before joining our staff. Their first-hand knowledge of regulatory policies and procedures gives you added assurance that you receive quality advice at a reasonable cost.

We can assist you in bringing new food and dietary ingredients/products to market and to assure that they are grown, processed/manufactured, labeled, stored distributed and/or offered for sale in compliance with the established regulations. We can also assure that pharmaceutical, medical device and cosmetic products comply with applicable regulations.

Foods

EAS offers a full range of food and food ingredient consulting, submission, and auditing services including:

• 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

EAS offers a full range of dietary supplement consulting, submission, and auditing services including:

• 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.

Cosmetics

EAS offers a full range of cosmetic consulting, submission, and auditing services including:

• Conducting audits of cosmetic manufacturers to assure compliance with GMP guidelines.
• Reviewing cosmetic labeling for compliance with FDA requirements.
• Evaluating the safety of cosmetic ingredients.
• Preparing color additive petitions for submission to FDA for approval.
• Designing clinical studies to document safety of ingredients, and to substantiate label claims.
• Serving as expert witnesses and providing testimony on litigation involving disputes over color/cosmetic regulatory matters.
• Serving as the U.S. Agent for foreign color manufacturers.
• Arranging and attending meetings with Agency officials on behalf of our clients.
• Interpretation of rulings and policies of FDA as they relate to products or practices.
• Providing updates and advice on current regulatory and policy developments at FDA and other government agencies.
• Providing guidance on import procedures, and assisting in obtaining clearance of products through U.S. Customs and FDA at time of entry.
• Providing management and employee training on color/cosmetic regulatory matters.
• Providing recall advice and assistance as needed.

Pharmaceuticals

EAS offers a range of pharmaceutical consulting and auditing services including:
Conducting cGMP, Quality System and pre-approval audits of manufacturers and vendors.

• Conducting due diligence audits.
• Providing consulting services related to FDA pharmaceutical policies and procedures.
• Interpreting FDA policy and guidance documents related to cGMPs.
• Reviewing laboratories for compliance with GMP requirements.
• Providing guidance on import procedures, and assisting in obtaining clearance of products through U.S. Customs and FDA at time of entry.
• Providing recall advice and assistance as needed.
• Preparing SOPs for complaint handling, recalls, change control, employee practices, failure investigations, etc.
• Prepare firms for FDA pre-approval inspections by conducting “FDA-like mock inspections”.
• Reviewing Chemistry and Manufacturing Control (CMC ) submissions to FDA.

Medical Devices

EAS offers a range of medical device consulting, submission and auditing services including:

• Preparation and submission of 510(k) Pre-market Notifications to FDA for approval.
• Conducting quality system audits of medical device manufacturers.
• Assisting medical device manufacturers implement quality control/assurance, regulatory affairs, document control, and complaint handling procedures.
• Providing consulting services related to FDA medical device policies and procedures.
• Providing recall advice and assistance as needed.

Tobacco

EAS offers a range of consulting, submission and auditing services, including:

• Assisting with regulatory compliance and submission requirements
• Preparing the industry for FDA tobacco GMPs
• Implementing FDA recognized quality systems
• Monitoring of FDA tobacco activities, dockets and regulation development

Expert Witness Services

In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference on how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective.

EAS offers one of the most experienced groups of experts available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years regulatory experience, and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts, while establishing credibility and persuasiveness as witnesses.

EAS offers assistance in adjudicating insurance claims, and servicing as an expert in depositions and civil litigation cases.

U.S. Agent Services

Food Facility Registration

Take the worry out of registering foreign food facilities to assure compliance with FDA regulations relating to the Bioterrorism Act. Use EAS as your U.S. Agent. EAS is located minutes from FDA Headquarters, and has consultants with many years of FDA experience.

EAS Consulting Group will:

• Collect all necessary registration information required by the Bioterrorism Act.
• Register with FDA each of your facilities that engages in the manufacturing/processing, packing, or holding of food for human or animal consumption in the United States.
• Update registration as changes occur.
• Automatically conduct annual reviews to assure that registration information is kept up-to- date.
• Provide you with a registration number from the FDA, which will be confirmation that your facility information has been properly entered into the FDA food registration system.

The benefits of using EAS’s U.S. Agent Services include:

• Low cost.
• Takes worry and hassle out of registration process.
• Assures registration is kept up-to-date.
• Develops a business relationship with experts in FDA regulatory matters.

Foreign Origin Color Manufacturers - Color Certification

EAS offers a U.S. Agent service to foreign color manufacturers for purposes of certifying FD&C colors. This service includes processing requests for certification and acting as a communication link with FDA’s Office of Cosmetics and Colors.

Seminars and Training

EAS offers a variety of public seminars at various times and locations throughout the year. These seminars are designed to help the regulated industry comply with today’s complex laws and regulations. They are taught by instructors that are experts in their field. Often the person teaching the course was responsible for writing, reviewing, or implementing the regulations when they were employed by FDA. Attending an EAS Seminar is a cost-effective way to learn from those that have an “insiders” perspective on FDA policies and procedures.

Check the schedule for currently planned seminars. If you don’t see what you are looking for, contact us with your training needs. We also conduct in-house training programs tailored to your specific needs. We want to help satisfy your training requirements.

FOI and Information Services

Using the power of the Freedom of Information Act (FOIA), EAS will secure public documents to drive improved knowledge management and enable you to make more informed decisions.