BARDA eCTD Templates Supporting Regulatory Submissions (Renewal of a Site License)
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Due: April 24, 2025 at 01:00 PM UTC
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Summary

The opportunity involves a sole source contract for the renewal of a site license for StartingPoint, which provides electronic templates for regulatory submissions compliant with eCTD specifications. The contract is intended for Accenture Federal Services LLC and is part of the efforts by the Biomedical Advanced Research and Development Authority (BARDA) under the U.S. Department of Health and Human Services. The work will include the procurement of Microsoft Word-based templates that adhere to FDA and ICH guidelines for CTD dossier content and format. This opportunity is suitable for contractors with expertise in regulatory compliance and electronic documentation, particularly those familiar with the pharmaceutical or biotechnology sectors.
Description

Notice of Intent to Sole Source

In pursuant to FAR 5.203(a), the Center for Biomedical Advanced Research and Development Authority (BARDA), which operates under the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Huma

Entities
HAHSDO
Department of Health and Human Services
NAICS
541512
Set Aside
None
Place of Performance
Washington , District of Columbia 20201
Point of Contact
Full Name Email Phone Type
Corneilus Stephens [email protected] 2027380221 primary