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About UsNorman F. Estrin, Ph.D., RAC

Established in 1990 by Norman F. Estrin, Ph.D., RAC, ECG is located close to FDA in Maryland and offers efficient, cost-effective service. ECG's emphasis is on medical device submissions but also is called upon to advise clients on other device issues as well as on cosmetic and pharmaceutical regulatory and business development 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. 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 (or approval) process significantly.

ECG also advises cosmetic and OTC drug clients in regulatory and business development areas. Other services include acting as an expert witness (for corporations) and assisting law firms in resolving technical and submission issues.

Services

Favorable, timely reviews of medical device submissions by the FDA do not happen by chance. They depend on sound planning, management and expert knowledge in the preparation of your submission. The alternative is a costly and frustrating process that will delay or prevent your product from getting to market.

ECG offers cost effective, experienced consulting to medical device firms on FDA-related issues. Its services include:

  • Preparing 510(k), IDE, PDP and PMA Submissions

  • Critique of Company-Devloped Draft Submissions

  • Response to FDA Deficiency Letters

  • Regulatory Strategy Development

  • Interpreting FDA Requirements

  • Preparing for and Participating in Meetings with the FDA

  • FDA Liaison

  • Regulatory Education and Training

  • Expert Witness Testimony

ECG is your submissions expert. ECG will ensure your technical information will fulfill FDA's latest requirements and facilitate its review. ECG's experience covers areas covered by the following Divisions of FDA's Center for Devices and Radiological Health (CDRH) including:

  • Clinical Laboratory Devices

  • Cardiovascular and Respiratory Devices

  • Dental, Infection Control, and General Hospital Devices

  • General, Restorative and Neurological Devices

  • Reproductive, Abdominal and Radiological Devices

  • Ophthalmic and ENT Devices

In addition, ECG offers services to the medical device industry through its referral network of consultants as well as services to the drug and cosmetics industries.

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: Contact Information :

9109 Copenhaver Drive, Potomac-20854 MD ,United States

Phone: (301) 279-2899

Fax : (301) 294-0126

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