Rare Disease Regulatory Operations Support Consultant
National Institutes of Health · NATIONAL INSTITUTES OF HEALTH NICHD
Capture briefs (a one-page, shareable copy of this page) are part of Pro. The CSV here holds the notice, its timeline and past awards.
Where this opportunity stands
Every notice posted under solicitation 75N98026R00147 in this department, oldest first.
- Aug 12, 2026 · this noticeSources Sought
Next steps for this stage
Standard steps for the notice type; not advice about this buyer.
- Answer the notice: this is when the requirement can still be shaped.
- Contact the contracting officer named on the notice.
- Check who won similar work; they are the likely bidders.
What the notice says
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 requir… (show all)
ed 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.
Who won similar work
5 award notices on SAM.gov in the last 24 months. Match: Same agency (National Institutes of Health), same NAICS 541690.
| Winner | Awards | Value | Last |
|---|---|---|---|
| DATACONSULT-IO LLC | 1 | $12.3M | Aug 1, 2025 |
| BHI MANAGEMENT INC | 1 | $1.0M | Sep 29, 2025 |
| ARALDI GIAN LUCA San Marcos CA 92069 USA | 1 | $250K | Sep 16, 2025 |
| Park Wall Technologies Ltd | 1 | $202K | Aug 4, 2026 |
| MIDNIGHT SUN PROFESSIONAL SOLUTIONS LLC | 1 | $12K | Nov 17, 2025 |
Value counts single-winner awards. "Shared" awards are multiple-award contracts that list every winner with the same total ceiling; that ceiling is not one company's win, so it is not added in.
- Aug 4, 2026Park Wall Technologies Ltd$202KScientific analysis and mathematical modeling of clinical research data
- Nov 17, 2025MIDNIGHT SUN PROFESSIONAL SOLUTIONS LLC$12KAssay Development Consultant Support Services
- Sep 29, 2025BHI MANAGEMENT INC$1.0MNIA Entrepreneurs in Residence (EiR) Support
- Sep 16, 2025ARALDI GIAN LUCA San Marcos CA 92069 USA$250KProcess Development Consultant Support Services.
- Aug 1, 2025DATACONSULT-IO LLC$12.3MAward - Neurodegenerative Disease Scientific Data Analysis Services
Competitive landscape
For the 5 most frequent past winners above. Lobbying is matched by the company's exact name or exact ticker; agencies are as named on the filings.
- 0 of these past winners lobbied Natl Institutes of Health (NIH) since 2024 (0 filings)
- 0 of their lobbyists list a past Natl Institutes of Health (NIH) job
- No corporate PAC money from them to the overseeing committees since 2024
- 0 foreign-agent (FARA) registrations
Policy around it
Bills the past winners named while lobbying this agency's issues, rules from the department, and executive orders that name the agency, last 12 months.
- 0 bills named on the past winners' lobbying filings
- 0 rules from the department in the last 12 months
- 0 executive orders naming the agency in the last 12 months
Market
For past winners matched exactly to a listed company. Insider trades are open-market buys and sells (Form 4) in the last 90 days, shown as facts; our own study found insiders do not reliably buy ahead of awards.
- 0 of the past winners are listed companies
- 0 insider buys and 0 insider sells at them in the last 90 days
Sources: SAM.gov notices and award notices; Senate LDA lobbying filings; FEC filings; FARA; Federal Register; congress.gov; SEC Form 4. Every row above links to its record.
Companies are matched to tickers by exact name only. A company we could not match shows no market rows; that is a miss, not a finding.