Articles

The Best Medical Device Expert Services Of FDA Consultant

by John Smith Digital Marketing Expert
Biotech Research Group is one of the full service regulatory and product development consulting firm. It has certified regulatory affairs professionals that have years of experience working with the FDA throughout the pharmaceutical, biologics, and medical device industries. This is to hire one FDA consultant when you can have a group of savvy FDA  consultants. It will carefully consider all strategies and alternatives during each step of the regulatory process. This consultant group has expertise with a wide range of medical devices across all classes.

FDA Consultants services 

This consulting group has an expert to provide the best support for their clients. FDA Consultants are in-depth knowledge on how to prepare all FDA drug submissions the following:

  • ANDA application (Abbreviated New Drug Application)
  • NDA application 505 (b)(2) (New Drug Application)
  • IND application (Investigational New Drug)
  • DMF application (Drug Master File)

The FDA will inquire about the manufacturing processes as well. Each milestone in the process is significant and if there is insufficient preparation, the drug development strategy will be flawed. FDA 510k consultant will ensure at the end of each FDA meeting, the client is clear with what is needed to move forward. Along with a well-developed strategy for your drug, Biotech Research Group offers the following services to clients:

  • FDA briefing package
  • Pre-IND meeting
  • FDA communications and meetings for all phases
  • Pre-NDA meeting
  • Orphan drug designation
  • Clinical trials coordination
  • Literature reviews
  • Scientific research
  • 513(g) Request for Information
  • ANDA suitability petitions
  • Technical documents review

Many FDA submissions are not approved initially. Biotech Research Group has the drug expertise you need to increase your chances of initial approval, saving you both time and resources.

Medical Devices Services 

- Medical device expert services are increasingly more challenging from a regulatory perspective. The Biotech Research Group is here to help you navigate through the FDA’s ever-changing world of regulations. They will take care of all matters concerning the regulation and compliance of your medical device or combination product. 

These  FDA consultants' services will prepare your 510k submission, plan to test, manage communications with the FDA and any other items that will be needed through the approval process or post-marketing requirements. 

Partnering their medical device expertise consulting with your internal 510k developers is a smart choice. They are allowing your medical devices to get to market faster without costly delays. Years of experience mixed with strategic approaches, allow you to maintain project control while accessing the specialized medical device expertise you need 24/7. There are Some of FDA 510k consultants services the following:

  • Pre-market requirements
  • Post-market requirements
  • 510k submission
  • De Novo submission
  • IDE submission
  • Pre-market approvals (PMA)
  • Medical device classification
  • Medical device registration & listing
  • Medical device recalls
  • Importing/ exporting medical devices
  • Combination products
  • FDA communications
  • 513(g) Request for Information
  • HUD / HDE submission

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About John Smith Senior   Digital Marketing Expert

343 connections, 4 recommendations, 973 honor points.
Joined APSense since, June 14th, 2012, From Delhi, India.

Created on Dec 4th 2019 06:54. Viewed 468 times.

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