SAM #75N98026R00147

NIH NINDS Rare Disease Regulatory Operations Consulting Services Solicitation

This opportunity from the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), seeks expert consulting services for rare disease regulatory operations supporting therapeutic biotechnology development. - Government Buyer: - National Institutes of Health (NIH) - National Institute of Neurological Disorders and Stroke (NINDS) - OEMs and Vendors: - No specific OEMs or vendors are named; focus is on professional consulting services - Services Requested: - Regulatory operations consulting for rare diseases, including FDA, EMA, and international regulatory affairs - Medical writing for regulatory submissions (INDs, CTAs, Investigator Brochures, Fast Track and Breakthrough Therapy Designations, Orphan Drug Designations, meeting packages) - Acting as EU Orphan Drug Designation (ODD) sponsor and representation - Management of up to 5 ODD applications annually - Expertise required in biologics product development, regulatory strategy, and orphan drug processes - Unique/Notable Requirements: - Contractor must provide milestone evaluation, document preparation, and regulatory representation - Demonstrated experience in rare disease regulatory consulting and biologics development is essential - Services are set aside for small businesses, including 8(a), small disadvantaged, woman-owned, service-disabled veteran-owned, and HUBZone firms - No products or part numbers specified; all requirements pertain to professional services - Period of Performance: - 3-year contract: 1-year base period, followed by two 1-year option periods - Up to 5 ODDs managed annually

Description

The National Institutes of Health (NIH), Office of the Director (OD) is conducting a market survey to determine the availability and technical capability of qualified small businesses, including 8(a) small businesses, small, disadvantaged businesses, woman-owned small businesses, service-disabled veteran-owned small businesses or HUBZone small businesses capable of providing the services of International Orphan Drug Designation (ODD) Sponsor/Representation, European Medicines Agency (EMA) and international regulatory consultants.

Interested firms with the capability of providing all the required services shall submit a capability statement to assist the Government in determining in accordance with the Federal Acquisition Regulation 19.104-1.

The intended procurement will be classified under North American Industrial Classification (NAICS) code 541690 with a size standard of $19m. All respondents are required to identify their firm’s size and type of business.  Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government’s requirements for the above. The capability statement shall be in sufficient enough details so that the Government can determine the experience and capability of your firm to provide the items and services in this posting/notice.    Offers must also be accompanied by applicable descriptive literature, delivery timeframe, warranties and other information that demonstrates that the offer meets all the foregoing requirements. Capability statements must include the name and telephone number, and email address of a point of contact having authority and knowledge to discuss responses with Government representatives.  Capability statements in response to the market survey that do not provide sufficient information for evaluation will be considered non-responsive.  A copy of the capability statement must be received via email to robinsti@mail.nih.gov  Attn: Tina Robinson prior to 10:30 am eastern daylight time on August 19, 2026.  Capability statement must reference solicitation#   75N98026R00147.  Submission by email must also reference solicitation # 75N98026R00147 on the subject line of the email. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# 75N98026R00147 on the subject line of email. Capability statements, etc will not be returned to firm/sender.  This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.  

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