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G&L – expediting the EUA process

December 3, 2021

Do you need assistance with Emergency Use Authorization (EUA) requests?

With a wealth of Emergency Use Authorization experience, and a preferred vendor for EUAs, G&L Scientific is the partner of choice  when aiming to expedite the whole application process.

G&L’s in-house experts can help successfully prepare an EUA application in, typically, 3–6 months from the date a contract is signed.

Our comprehensive, four-phase process covers all requisite steps to achieving authorization and includes:

  • Phase 1 – Data/document review, gap analysis of development program, and regulatory roadmap to include risk management plan
  • Phase 2 – FDA engagement strategy: composition of meeting request, briefing document compilation and sponsor presentation (if required)
  • Phase 3 – Implement FDA recommendations and prepare EUA submission and submit to FDA
  • Phase 4 – Post-submission support*

*If the FDA requires an Advisory Committee meeting to deliberate over your EUA application, G&L can also provide full technical writing support to prepare your company’s meeting package.

For more information on how G&L can assist you with Emergency Use Authorization requests please complete the Contact form here.

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