EAS Consulting Group - Your Dedicated U.S. Agent

EAS provides a variety of FDA based regulatory services to the global Rx and OTC pharmaceutical industry.We offer a seamless approach to help your organization navigate the regulatory intricacies associated with product development, submissions, claims and labeling,manufacturing and packaging of commercial products,as well as facility and product registrations and listings. Our team of pharmaceutical regulatory experts are ready to provide assistance in; the development of filing and quality strategies, GMP/GLP/GCP assessments, Mock-FDA Inspections and reviews, quality management system development, regulatory submissions, product labeling and claims compliance, and a number of other topics  that will help your organization succeed in this highly complex and very competitive regulatory environment. EAS is committed to helping the members of domestic and international pharmaceutical market understand,meet and sustain compliance with the FDA’s numerous requirements in a manner t

EAS provides a variety of domestic and international regulatory services to industries under FDA oversight including in-depth expertise and guidance in the areas of Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs),Good Clinical Practices (GCPs), and Good Documentation Practices (GDPs) for all FDA regulated industries. EAS conducts compliance assessments and mock FDA inspections for manufacturers, packagers, distributors, Own Label Distributors, contract manufacturers, laboratories, Research& Development facilities, Contract Research Organizations and more. Our seamless approach helps organizations navigate the many regulatory requirements for compliance with quality management and system development. Whether your firm is involved with the manufacturing, packaging,distribution of products; ingredients and additives; or is a testing or research laboratory facility; EAS is committed to helping you understand, meet and sustain compliance with the FDA’s numerous

The FDA has established a wide variety of product submission requirements across the pharma, device and other regulated segments.Whether you are seeking assistance with an ANDA, DMF, 510(k), GRAS/NDI or a color certification, EAS Consulting Group is a valuable partner in the development and execution of an effective regulatory filing plan to achieve a successful submission. Our team of experts will work with you throughout the product development and submissions life cycle to help you identify the regulatory requirements,assemble product dossiers, evaluate the studies and draft the required submissions documents to give your file the best advantage for successful review by the FDA. We can also assist in maintaining the required facility registrations and product listings as your U.S. Agent

EAS Consulting Group, LLC is a leading provider of regulatory services to the pharmaceutical, medical device, food, dietary supplement, tobacco, and cosmetic industries. Whether your firm is looking for an expert witness in litigation involving FDA requirements, policies,and procedures; remediation, warning letters and 483 responses, or assistance with the preparation and submission of regulatory documents, audits and investigations, EAS senior consultants with both FDA and high-level industry experience can provide valuable assistance.