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Regulatory & Translational Strategy Consulting

Active

Federal

Response Deadline07/09/2026, 01:00:00 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 involves providing specialized advisory services to support the development of a gene therapy product through IND-enabling activities, with a focus on regulatory planning, safety and toxicology study design, and the strategic transition to GMP-compliant manufacturing processes. The work requires deep expertise in navigating regulatory pathways for advanced therapeutic products and ensuring that preclinical data packages meet FDA expectations for investigational new drug applications. Services will be delivered under a subcontract arrangement with the National Institutes of Health under the Department of Health and Human Services, and the effort is categorized under NAICS code 813920 for other technical and trade schools, indicating a specialized consultancy nature. The solicitation was posted on June 30, 2026, and responses are due by July 9, 2026, with no specific location for performance identified, allowing for remote or distributed delivery. There is no set-aside designation specified, meaning eligibility is open to all qualified entities. The advisory work is critical to bridging preclinical development and clinical initiation, requiring alignment between scientific rigor and regulatory compliance to de-risk the gene therapy program’s progression.

General Info

Advisory services for gene therapy IND-enabling activities, regulatory planning, safety studies, and GMP transition under NIH subcontract.

Agency

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

NAICS

813920 - Professional Organizations View NAICS

Place of Performance

MD

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedJun 30

subcontract

Response DeadlineJul 9

Submission deadline

Response Deadline

07/09/2026, 01:00:00 PM UTCin 4 days

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Organization & Contact Information

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

ContactsNo contacts available

OfficeN/A

Organization / Agency

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

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

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Advisory services for IND-enabling studies, including regulatory planning, safety/toxicology design, and GMP transition strategy for gene therapy development.

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