Covid-19 Emergency Response, Emergency Use Authorization Response

Contact us today to learn how QA/RA Consulting Group can assist you.

QARA CG is committed to responding to a growing and urgent need throughout the United States for critical Personal Protective Equipment (PPE), including N95 masks (Industrial and Medical), Gowns, Surgical Masks, Nitrile Gloves, Protective Face Shields, Thermometers, and lab supplies due to the Coronavirus outbreak.

QARA CG can enable the export of Personal Protective Equipment (PPE) by expediting FDA registration and providing mandatory U.S. Agent services. We will also act as your FDA Official Correspondent for 2020 at no additional charge.

 

Manufacturers of any of the following products can complete and submit the FDA Establishment Form linked below immediately to begin FDA registration.

  • N95 Masks

  • KN95 Masks

  • Surgical Masks

  • Nitrile Gloves (all sizes)

  • Protective Face Shields

  • Single-Use Thermometers

  • Lab Supplies

QARA CG is committed to supporting manufacturers of PPE beyond 2020, and can provide continued FDA representation as a U.S Agent and FDA Official Correspondent beyond 2020 for an annual fee. 

Manufacturers of other medical devices should contact QA/RA Consulting Group at info@qaraconsultinggroup.com. An Industry Consultant will reply to all other requests in the order in which they are received.

QARA CG will provide your Certificate of FDA Registration, list your products with the US FDA ($5236 value for 2020), and will represent your company as a mandatory U.S. Agent and an FDA Official Correspondent for 2020.

QARA CG will complete all necessary forms and paperwork and communicate with FDA regarding the products your company can provide, and issue a Certificate of FDA Registration within 24 hours.

$6295

Contact us today to learn more about how QA/RA Consulting Group can assist you.

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