Established in 1990 by Norman F. Estrin, Ph.D., ECG is located close to FDA in Maryland and offers efficient, cost-effective service. ECG is called upon to prepare 510(k) medical device submissions and to advise clients on cosmetic labeling and OTC drug and dietary supplement areas. ECG President, Dr. Norman Estrin, has over 30 years of experience on FDA issues.
ECG's strengths are its personalized service and in-depth understanding of the rapidly changing regulatory environment. Its principal, Norm Estrin, coordinates with the client to organize and develop most submissions. Other consultants and attorneys are brought in only with the client's concurrence and when specialized expertise is required. In this way, ECG has helped clients to resolve manufacturing, quality and compliance issues.
ECG's philosophy in preparing regulatory submissions is to couple the client's expertise in the technology with ECG's expertise in preparing regulatory submissions and dealing with the FDA. ECG's job is to work very closely with the client to ensure that technical information can be translated into a form acceptable and clear to the FDA in order to facilitate its review. Through use of all applicable guidance documents and personal contacts with FDA officials and the regulatory community, ECG helps ensure that the submission reflects the latest FDA thinking. Solid scientific data from the client, put into an easy-to-follow format, helps reduce the number and frequency of FDA questions, which can slow down the clearance process significantly.
ECG also serves as an expert witness and assisting law firms in resolving technical and submission issues.