EAS Consulting Group LLC

Alexandria,  VA 
United States
http://www.easconsultinggroup.com
  • Booth: 2551

EAS Consulting Group, LLC (EAS) is a leading provider of FDA regulatory consulting services, with over 50 years of experience in helping firms to navigate applicable laws and regulations. We have assisted thousands in all matters of FDA regulatory issues, from performing cGMP audits and mock FDA inspections, quality system implementation and remediation, product development and regulatory strategies, to submissions, filings, registrations, assistance with imports and acting as a US Agent. EAS offers over 150 independent consultants, specialists in their fields and former FDA officials and high level industry executives, who provide unparalleled expertise pertaining to your specific needs. Visit our website, www.easconsultinggroup.com to learn more about our consulting and auditing services, or stop by our CPhI booth, #2551, to discuss your needs with our experts.


 Press Releases

  • EAS Consulting Group, LLC is very pleased to welcome Domenic Veneziano as the new Independent Advisor for Import Operations.  Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. While at FDA, he was a Captain in the US Public Health Service serving most recently as director of the FDA’s Division of Import Operations, overseeing all aspects of FDA’s import operations program.  During his tenure at FDA, Mr. Veneziano also served as the co-lead in the development of FSMA import regulations and was a senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act.  His addition to the EAS senior leadership team of independent advisors further solidifies EAS as the leading consulting company specializing in matters pertaining to all FDA regulated areas. 

    Mr. Veneziano’s expertise will provide invaluable assistance to companies seeking to develop strategies for the prevention of adulterated products, compliance with Good Manufacturing Practices and support the development of policies and procedures that meet FDA’s stringent standards.  Navigating FDA’s new and complex regulations pertaining to imports can be challenging and Mr. Veneziano, with his in-depth knowledge of FDA law, will provide EAS clients the peace of mind that their efforts are in-line with agency requirements. 

    Domenic Veneziano joins a team of EAS Independent Advisors, leaders in their fields in developing regulatory compliant strategies, and providing expert regulatory advice: 

    • Jeffrey Springer, FDA Regulatory and Legal Matters,

    • Elizabeth Campbell, Labeling and Claims,

    • Stephen Sundlof, D.V.M., Ph.D., Animal and Human Food Safety,

    • Robert L. Martin, Food and Color Additive Safety,

    • Charles Breen, FSMA Consulting Services,

    • Robert Fish, Quality and Compliance,

    • Nancy Chew, New Product Development and Submissions,

    • John Bailey, Colors and Cosmetics,

    • Susan Crane, OTC Drugs and Labeling,

    • Tara Lin Couch, Ph.D., Dietary Supplements

    Mr. Veneziano and the rest of the EAS advisors are supported by a network of over 150 of the consulting industry’s most experienced regulatory consultants.

    “We welcome Domenic Veneziano and are pleased that EAS continues to provide an unparalleled level of technical consultation for our clients,” says EAS Chairman and CEO Edward A. Steele.  “Mr. Veneziano’s  comprehensive assessments and recommendations in the complicated area of FDA imports will enable clients to successfully develop and implement policies in compliance with not only FDA regulations but also their long-term business goals.”

    About EAS Consulting Group, LLC
    While EAS Consulting Group celebrates its tenth year of service under the name EAS, it continues to carry on 55 plus years of leadership in providing regulatory consulting to the industries regulated by FDA.   Our network of independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services to the supplement, pharmaceutical, medical device, food, tobacco and cosmetic industries.  Whether the need is assistance with product development, tailored compliance trainings, 483 responses, mock-FDA audits, expert witness services, labeling compliance or 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 regulatory matters.


 Products

  • Pharmaceutical Regulatory Services
    EAS is a leading provider of regulatory consulting services to the pharmaceutical industry. The firm has over 50 years of experience assisting clients in developing strategies, quality assurance programs and ensuring compliance with FDA regulations....

  • EAS Consulting Group, LLC (EAS) provides pharmaceutical consultation services to assist you with product development and registration and GMP compliance, taking your new product through the regulatory evaluation process and obtaining marketing approval from regulatory bodies, such as the FDA.  We offer assistance with regulatory strategies and compliance, mock-FDA and GMP audits, assistance with labeling compliance as well as training.  Employing a unique team of former FDA officials and industry experts, EAS offers unparalleled expertise with most consultants having more than 30 years of FDA experience.

  • US Agent Services
    EAS Consulting Group provides U.S. Agent services to international clients in various FDA regulated areas to register the facility or products as needed and acts as a conduit of information between FDA and the foreign firm....

  • EAS Consulting Group provides U.S. Agent services to international clients in various FDA regulated areas to register the facility or products as needed and acts as a conduit of information between FDA and the foreign firm. By quickly responding to questions and concerns in a timely manner EAS helps clients get their compliant products to the U.S. marketplace as quickly as possible.

    EAS serves as the U.S. Agent for foreign color manufacturers who are required by law to submit each batch of color for certification by FDA. EAS submits these colors to FDA for testing and serves as intermediary between the foreign manufacturer and FDA.

    Our team of qualified experts submit establishment registration and process filing forms on behalf of foreign firms that manufacturer acidified or low acid canned foods for sale in the U.S. 

    We also assist with products which are being held under FDA detention.  Whether the issue is lack of prior notice, inaccurate labeling and claims, LACF registration problems or other issues, our experts in import issues will work with the authorities and your company to solve the issues surrounding your product’s detention.

  • FDA Submission Assistance Services
    EAS Consulting Group can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts such as toxicology, radiology, chemistry and biology and authorities in government laws and regulations....

  • EAS Consulting Group, LLC (EAS) can make recommendations and provide assistance with FDA submissions for your product(s). With scientific experts such as toxicology, radiology, chemistry and biology and authorities in government laws and regulations, EAS’ consultants can lead your company through the process of obtaining necessary background data, filing the submissions, and following-up as needed during the submission process.

    We offer submission filing assistance for Foods, such as Generally Recognized as Safe (GRAS), New Dietary Ingredients (NDI), Infant Formula Notifications, Food Facility Registration, Low-Acid Canned Foods (LACF) and Acidified Foods (AF); Medical Devices such as 510(k)s, Premarket Approvals, Establishment Registration and Product Listings, Investigational Device Exemptions (IDE); Pharmaceuticals such as Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), Investigational New Devices (IND), Drug Master Files (DMF), Structured Product Labeling (SPL) and Color Certification Submissions.