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Emergency Use Authorization Requests

Preparation of Emergency Use Authorization (EUA) requests

G&L Scientific is a preferred vendor for Emergency Use Authorization requests (EUAs) and can assist with the preparation of all requests in order to expedite approval.

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

Our detailed four-phase process covers all essential steps to 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 below.

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For more information on Emergency Use Authorization, please fill in the form and we will respond to you as soon as possible.

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