Rare Disease Regulatory Operations Support Consultant
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026R00147
- Agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health, Office of the Director, is conducting a market survey to identify qualified small businesses capable of providing International Orphan Drug Designation sponsor representation, European Medicines Agency regulatory consulting, and related international regulatory support services, with capability statements due by August 19, 2026. This procurement is set aside for Total Small Business, including 8(a), small disadvantaged, woman-owned, service-disabled veteran-owned, and HUBZone small businesses.
The Statement of Work calls for subject matter expert consulting across three performance areas: regulatory affairs (FDA, EMA, and international strategy for rare disease therapeutics, including IND/CTA preparation and orphan drug designation support); medical writing (regulatory document and clinical protocol preparation for FDA and EMA submission); and orphan drug designation sponsor representation (serving as legal EU ODD sponsor for up to five designations annually, managing post-designation compliance, and maintaining EMA communication). Regulatory affairs experts must hold a minimum MS, PhD, or MD with at least 10 years' experience in biologics product development, regulatory strategy, and rare disease programs. Medical writing experts require at least 5 years' experience with regulatory submissions and clinical documents, including ICH-GCP guidelines and eCTD format familiarity. ODD sponsor/representation experts must be legally established in the European Economic Area or appoint an EU legal representative, with at least 5 years' experience managing EMA IRIS submissions and orphan drug documentation.
The contract period spans three years (Base: September 21, 2026–September 2027; Option 1: September 2027–September 2028; Option 2: September 2028–September 2029), with primary performance at the contractor's site and supplemental work via conference calls, email, and occasional on-site visits at government or investigator facilities. The NAICS code is 541690 with a $19 million size standard.
Notice text
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.
Files
| File | Type | Posted |
|---|---|---|
| SOW Rare Disease Regulatory Operations Support.pdf |
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