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About
Us
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
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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. |
