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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.

Contact us today

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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