MRDC Office Regulated Activities Support Services

MRDC requires Office of Regulated Activities support services under a professional services IDIQ contract.

Solicitation Summary

The Department of the Army, Army Futures Command, Medical Research and Development Command (MRDC), has a requirement for Office of Regulated Activities (ORA) Support Services.

Solicitation in a Nutshell

Item

Details
Agency Department of the Army, Army Futures Command, Medical Research and Development Command (MRDC)
Solicitation Number HT9425ORARFI
Status Pre-RFP
Solicitation Date 04/2026 (Estimate)
Award Date 07/2026 (Estimate)
Contract Ceiling Value $95,000,000
Competition Type  Full and Open / Unrestricted
Type of Award  IDIQ – Agency Specific
Primary Requirement  Professional Services
Duration N/A
Contract Type  Firm Fixed Price,Indefinite Delivery Indefinite Quantity,Time and Materials
No. of Expected Awards N/A
NAICS Code(s):
541990

All Other Professional, Scientific and Technical Services
Size Standard: $19.5 million annual receipts
Place of Performance:
  • United States
Opportunity Website: https://sam.gov/opp/2cb61f9bfa8f4461a0ae235ec2bed3f9/view

Requirements

  • This requirement is for (1) regulatory consultation, (2) regulatory oversight, and (3) Contract Research Organization (CRO) support to include administrative, financial, clinical, nonclinical, manufacturing, product accountability, quality support and regulatory support for medical products to include but not limited to: drugs, biologics, medical devices, and combination products to support the medical product development mission as is necessary to facilitate full program coordination, management, policy development, execution, and oversight across all of ORA.
  • The ORA provides regulatory and clinical support for the life cycle development of the Food and Drug Administration (FDA) regulated medical products sponsored by the Department of Defense (DoD) in addition to providing consultative support for medical products that are sponsored by other organizations. ORA has a requirement to provide various levels of support as defined below to enable product development of medical products, enable submissions to the FDA, and ensure all Code of Federal Regulations (CFR) Sponsor responsibilities are met in a manner consistent with FDA guidance and industry best practices.

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