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Regulatory Submission Support (IND-Enabling Package Assembly)

Active

Federal

Response Deadline08/18/2026, 07:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The contract mandates the compilation, organization, and formatting of preclinical study data, protocols, and reports into fully integrated regulatory dossiers that meet the FDA’s electronic Common Technical Document requirements for Investigational New Drug submissions. This work involves ensuring all documentation is accurately structured, consistently formatted, and compliant with current regulatory standards to support the successful submission of IND packages. The contractor is expected to possess deep expertise in regulatory affairs, eCTD structure, and preclinical data management to deliver high-quality, audit-ready submissions on schedule. The task is issued as a subcontract under the National Institutes of Health NIDA, part of the Department of Health and Human Services, with performance based in Bethesda. The solicitation was posted on August 3, 2026, and responses are due by August 18, 2026. The North American Industry Classification System code 541690 indicates the work falls under other scientific and technical consulting services. There is no set-aside designation, and no specific point of contact is provided; all submissions must be made through the designated SAM.gov portal.

General Info

Compile and format preclinical data into FDA-compliant eCTD submissions for NIDA-funded IND packages in Bethesda.

Agency

Department Of Health And Human Services → National Institutes Of Health NidaView Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedAug 3

subcontract

Response DeadlineAug 18

Submission deadline

Response Deadline

08/18/2026, 07:00:00 PM UTCin 13 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nida

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health Nida

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

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Compile and format preclinical study data, protocols, and reports into integrated regulatory dossiers compliant with FDA eCTD requirements for IND submissions.

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