FDA Scientific & Regulatory Support Services(SRS)

This is not a solicitation announcement.  This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFP, if issued.  The purpose of this sources sought synopsis is to gain knowledge of potential qualified vendors to include potential 8(a) vendors 8(a) relative to the North American Industry Classification System (NAICS) code and capable of providing multidisciplinary scientific and regulatory professional services in support of FDA Centers and Offices.

Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources. 

Project Title: FDA Scientific and Regulatory Support Services (SRS) IDIQ

Background/Overview: The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation's public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products, foods, and animal products, and by promoting innovation that addresses unmet medical and public health needs.

FDA decisions must be based on the best available scientific data and employ the best tools and methods available to ensure products meet the highest quality standards, while fostering innovation in the products it regulates. In support of its regulatory mission, FDA conducts scientific research across a broad range of disciplines including vaccines, drug safety, food safety, medical devices, biologics, toxicology, radiological products, and more. FDA's science is increasingly data-centric, complex, and collaborative, involving multidisciplinary groups across its Centers and Offices. Within the Center for Drug Evaluation and Research (CDER), the Office of Computational Science (OCS), established under the Office of Translational Sciences, supports the data management, technical, and analytic needs of the regulatory review process. OCS manages and supports analytical tools, data standards, and computing infrastructure that form the backbone of modern regulatory review for medical products.

Purpose: The FDA is seeking information from experienced sources in Scientific and Regulatory Support Services as it is contemplating the establishment of a Indefinite Delivery Indefinite Quantity (IDIQ) to such services. The FDA’s primary objective for this effect is to obtain Contractor services related to scientific and regulatory support across a broad range of mission requirements. Depending on the requirement, services may support scientific research, regulatory review, clinical and non-clinical analyses, epidemiology and surveillance, scientific data interpretation, laboratory activities, technical writing, training, and scientific program coordination.

Objectives: The objective of the contemplated SRS acquisition is to provide FDA with responsive, high-quality scientific and regulatory support across a broad range of mission requirements. Depending on the task order, services may support scientific research, regulatory review, clinical and nonclinical analyses, epidemiology and surveillance, scientific data interpretation, laboratory activities, technical writing, training, and scientific program coordination.

The Government is interested in sources capable of providing the scientific depth and operational capacity needed to:

• Conduct scientifically sound analyses and prepare defensible, traceable technical products supporting FDA review and public-health decisions.
• Provide qualified personnel across multiple scientific and regulatory disciplines, including specialized and emerging areas.
• Support clinical and nonclinical study-data review, standardized scientific datasets, statistical computing, data fitness, quality assessment, and interpretation.
• Respond to multiple simultaneous task orders, changing priorities, time-sensitive scientific questions, and evolving requirements across FDA organizations.
• Maintain scientific quality, data integrity, documentation, confidentiality, and continuity of performance.
• Deliver effective scientific training, technical writing, knowledge transfer, and program-management support tied directly to scientific and regulatory missions.

Project Requirements: The following descriptions are illustrative of the types of services that may be ordered. They are provided to inform industry responses and do not establish final task-order requirements. Each task order would define its own objectives, tasks, deliverables, performance expectations, staffing qualifications, and period of performance.

Scientific Research and Regulatory Review Support: Support scientific investigations, literature and evidence reviews, research planning, study design, methodological assessments, scientific consultations, and technical analyses relevant to FDA-regulated products. Prepare scientific assessments, briefing materials, review support documentation, and other products that allow Government scientists and reviewers to evaluate scientific evidence and communicate findings. Provide subject-matter expertise to address complex or emerging regulatory science questions.

Clinical and Nonclinical Study-Data Review and Analysis: Support the scientific review of clinical and nonclinical datasets submitted for regulatory purposes, including data fitness and completeness assessments, exploratory safety analyses, descriptive and inferential statistical analyses, and preparation of tables, listings, figures, and visualizations. Experience with standards such as CDISC SDTM, ADaM, and SEND may be relevant. The RRS BPA describes review-oriented services that assess study data and produce analyses for FDA reviewers; SRS would focus on the scientific and analytical performance of those services rather than maintenance of the underlying software platforms.

Epidemiology, Biostatistics, Pharmacovigilance, and Surveillance: Conduct epidemiological and Pharmacoepidemiological research, biostatistical analyses, pharmacovigilance assessments, signal detection and evaluation, public-health surveillance, and interpretation of real-world data and evidence as required by individual scientific programs. Activities may include protocol and analysis-plan support, assessment of study limitations and bias, statistical programming, results interpretation, and technical reporting.

Scientific Data Standards, Quality, and Analytics: Provide scientific expertise related to data standards, controlled terminology, study-data interpretation, data quality and fitness, and reproducible analytical methods. Support scientific data preparation and validation, biostatistics, bioinformatics, computational science, and other specialized analyses when the primary deliverable is scientific or regulatory in nature. Distinguish these activities from enterprise database administration, application development, platform engineering, and IT operations.

Laboratory and Specialized Scientific Support: Provide laboratory-related scientific and technical expertise, research assistance, analytical method support, study coordination, quality documentation, and interpretation or reporting of laboratory findings where required by a task order. Respondents should identify the specific laboratory disciplines, facilities, qualifications, and methods they can support rather than assume that all clinical trial operations or laboratory testing will be included.

Scientific Writing, Training, Knowledge Management, and Communications: Develop scientific reports, regulatory review support materials, technical summaries, study documentation, research publications, presentations, training curricula, and knowledge-transfer materials. Provide specialized scientific and regulatory training, including instruction related to study-data standards and analytical methods. Communications and knowledge-management work should be directly connected to scientific or regulatory activities rather than general enterprise communications or IT support.

Scientific Program and Project Management: Plan and coordinate scientific studies and projects; manage milestones, deliverables, schedules, staffing, and technical reporting; facilitate multidisciplinary collaboration; track performance and quality; and support continuity during transitions. Such activities must be integral to scientific and regulatory service delivery, not standalone enterprise IT project management.

Scope Distinctions: The contemplated SRS acquisition is not intended to replace vehicles for enterprise IT architecture, systems or application development, cloud or data-platform operations, infrastructure administration, software maintenance, generalized service-desk support, or other predominantly IT functions. Where a task combines scientific analysis and enabling technology, the Government will determine the appropriate vehicle and scope based on the primary purpose of the requirement. The final boundary between SRS and remaining RRS or other vehicles is subject to FDA and OAGS confirmation.

Capabilities and Technical Experience: Interested small businesses should submit a concise capability statement demonstrating relevant, actual performance and capacity to satisfy the contemplated requirements. Responses should clearly distinguish capabilities performed by the respondent from those provided by subcontractors, affiliates, or proposed teaming partners. FDA is particularly interested in the following:

Relevant Experience: Describe comparable scientific and regulatory engagements, customer organizations, contract or order identifiers where releasable, approximate value, period of performance, work performed, disciplines supported, and measurable outcomes. Explain how the experience relates to the breadth and complexity of the contemplated SRS work.

Scientific and Regulatory Disciplines: Describe the service areas the respondent can perform, with concrete examples involving scientific research, regulatory analysis, clinical/nonclinical datasets, statistical methods, epidemiology, laboratory work, scientific writing, and training as applicable. Do not claim disciplines for which experience cannot be substantiated.

Workforce and Concurrent Delivery Capacity: Describe the organization's demonstrated ability to recruit, retain, and deploy highly specialized scientific and regulatory professionals across a broad range of disciplines, including individuals with advanced degrees, niche technical expertise, and experience supporting complex scientific and regulatory programs. FDA recognizes that certain highly specialized skill sets may require recruitment from an international talent pool, including individuals holding or requiring employment-based visa sponsorship (e.g., H-1B) or other appropriate work authorization. Respondents should describe their experience recruiting and retaining such personnel, managing applicable sponsorship and work authorization requirements, and mitigating potential staffing disruptions during contract transitions. Responses should also address the organization's ability to fill hard-to-recruit positions, maintain continuity of specialized expertise, accommodate surge requirements, and support multiple concurrent task orders.

Scientific Quality and Data Practices: Describe scientific quality-control procedures, independent review, data integrity and reproducibility practices, use of applicable scientific standards, confidentiality controls, and experience handling sensitive regulatory or research information.

Representative Complex Requirement: Describe one or more specific scientific or regulatory assignments presenting substantial technical complexity, urgent timelines, or multidisciplinary coordination. Explain the challenge, approach, expertise, deliverables, and outcomes.

Teaming and Prime-Contractor Role: Describe anticipated prime, subcontracting, joint-venture, or teaming arrangements and the work each participant would perform. Explain how the prime would exercise management and technical oversight while meeting applicable small-business requirements.

Contract Structure Feedback: Identify whether the firm could support the full breadth of contemplated services or a defined subset and explain why.

Instructions for Responses:

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method.  Page limit: Maximum 15 pages (font size Times New Roman 11 or larger).  A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions).  The anticipated period of performance is a 5-year ordering period. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

In addition to responses to the below questions, each vendor responding to this SSN shall also fill out and provide responses to “Attachment B-Vendor Feedback Form.” The Vendor Feedback Form is not included in the 15-page limit. A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions or the Vendor Feedback Form). 

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Is your business a small business under the NAICS code?
2. Is your firm certified under Section 8(a) of the Small Business Act?

Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (Attachment A).

1. All interested parties can provide written opinions on the draft Statement of Work. 
2. All opinions expressed should focus on strengthening the draft Statement of Work Tasks to ensure industry understands and comprehends the government’s requirements. 

Business Status

1. Provide the legal business name and address
2. Primary point of contact and the contact information
3. SAM.gov Unique Entity Identifier (UEI)
4. CAGE code
5. Proposed NAICS code and size status
6. Applicable small-business socioeconomic designations (including 8(a), HUBZone, service-disabled veteran-owned, veteran-owned, women-owned, or small disadvantaged business, as applicable)
7. Identify whether the respondent proposes to participate as prime contractor, joint venture, or subcontractor

Responses to this notice shall be submitted via e-mail to Amanda Edger, Contract Specialist, at Amanda.Edger@fda.hhs.gov (with a CC: to Ian Weiss, Contracting Officer, at Ian.Weiss@fda.hhs.gov), by November 19, 2026, at 2:00 pm. After a review of the received responses, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

No solicitation is currently available.  This is not a request for proposals and in no way obligates the Government to award any contract.  Responses to this Sources Sought Notice will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation.  Ref. No. FDA-RFI-75F40127R00007/ALP No. OMITS-2027-136942.