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Regulatory Strategy and FDA/EMA Submission Support

Active

Federal

Response Deadline08/19/2026, 02:30:00 PM UTC

Contract Overview

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

General Info

Agency

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

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

SBA

Documents

This scope was carved out of 75N98026R00147.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Rare Disease Regulatory Operations Support Consultant

AI Contract Breakdown

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No contract breakdown available.

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Timeline

PostedAug 12

subcontract

Response DeadlineAug 19

Submission deadline

Response Deadline

08/19/2026, 02:30:00 PM UTCin 6 days

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Organization & Contact Information

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

ContactsNo contacts available

OfficeN/A

Organization / Agency

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

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

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Develop regulatory strategies for rare disease therapeutics, manage IND/CTA submissions, advise on clinical study design, and support FDA/EMA interactions including Type A/B/C and INTERACT meetings.

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