Role of Consultants

Why Consultant is required for listing your product with US FDA?

The following are the major reasons why organizations requires the technical support and guidance from consulting teams like AVSCS

  1. 21 CFR 820 GAP Analysis
  2. The GAPs need to be closed. We will provide consultancy for 21 CFR 820
  3. Act as your US Agent.
  4. Establishment Registration of your firm
  5. FDA 510k Guidance
  6. Advice on testing standards and selection of Laboratories.
  7. 510k - Notification Preparation
  8. Arrange third party reviewers, if required.
  9. Communicate with FDA on behalf of our client
  10. Prepare clarifications to questions from FDA
  11. 510k - Notification submission.
  12. Labeling Review
  13. Listing of Medical Device

Benefits of our Consulting service for FDA 510k:
  • All our consultants are experienced in Medical Device and pharmaceuticals domains
  • We provide one stop point service to medical device industries worldwide starting with (a) Medical Device Facility Design (b) National and International Regulatory compliances (c) Trainings etc…
  • Payments based on deliverables (Stage wise payment). Payment option in INR, USD & EUR.
  • Experience counts more than anything!!! We have…..

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :-
Telephone :- +91 - 9881946595

Design & Developed By : Logic Palace Systems and Softwares
Back to Top