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. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.
EAS offers one of the most experienced groups of consultants 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. With high level experts in all areas of FDA regulations, EAS is well recognized as representing industry in all manner of court cases.