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USFDA and 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 I 3 Consulting

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

Benefits of Consulting service for FDA Registration or 21 CFR 820 or FDA 510k:

  • All our consultants are experienced in Medical Device and pharmaceuticals domains
  • Started in the year 2000 and by 2012 we provided service for 1328 organization worldwide for different regulatory requirements.
  • 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.
  • The maximum allocated projects to Sr. consultants are 3 Nos. and Jr. Consultants is 2 Nos. in a month.
  • Experience counts more than anything!!! We have...

Applicable Fee

Further information please contacts us. Our consultants will be in touch at the earliest

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