Eye Product Assistance Center Subject Matter Experts

VentureWell is seeking subject matter experts for the National Eye Institute's Eye Product Assistance Center to provide consulting in regulated medical product development, regulatory affairs, clinical planning, and related technical areas.

Sourcewell


General
Open
#26-07
Dec 18, 2026 07:00 PM
Sep 02, 2026 04:30 PM
10 months
Request for Quote/Qualifications (RFQ)
Private
Ask AI about this solicitation
Contact
vendormanager@venturewell.org
Submission Instructions
Online
Capabilities Statement, Completed solicitation questionnaire, Relevant certifications, where applicable
Description

VentureWell is seeking qualified subject matter experts to support the National Eye Institute's Eye Product Assistance Center (EPAC), which assists investigators developing regulated products for diseases and disorders of the visual system. Relevant expertise includes needs assessment; device design and prototyping; chemistry, manufacturing, and controls; assay development and biostatistics; pharmacokinetics, pharmacodynamics, and ADME; toxicology; quality assurance and quality control; regulatory affairs and operations; medical writing; and first-in-human trial planning. Respondents need experience in only one or more of these areas, while visual-system or ophthalmic experience is preferred. Eligibility requires a UEI for entities contracted with an EIN, either a bachelor's degree with at least 10 years of relevant experience or a master's degree with at least 7 years of relevant experience, applicable professional certifications where relevant, and no conflict of interest with supported investigator teams. Selected experts will provide targeted, in-kind consulting to assigned investigator teams, translate technical and regulatory guidance into actionable recommendations, participate in presentations or decision meetings, attend program meetings when requested, provide project updates, and submit invoices. Engagements may be structured as time-and-materials or firm-fixed-price contracts; time-and-materials requests for a single performer are capped at approximately 30 hours at a rate of $275 per hour, with work outside an authorized delivery order uncompensated. The solicitation establishes a qualified source list and may result in multiple awards or later offers for project-specific scopes. Required response materials include a capabilities statement, a completed solicitation questionnaire, and relevant certifications where applicable; an individual resume, CV, or biosketch is optional for individuals. The capabilities statement must address technical capabilities, proposed approach, and three examples of similar past work, with each section limited to 500 words.

Classification Codes
NAICS541690Other Scientific and Technical Consulting Services
PSCR528STUDY/REGULATORY
Smart Codes
medical product development consultingregulatory affairs consultingmedical writing consulting
Specifications
Service Only
Timeline
Sep 02, 2026 04:30 PM-Solicitation Open Date
Dec 18, 2026 07:00 PM-Intent to Bid Due Date
Dec 18, 2026 07:00 PM-Proposal Due Date
Dec 21, 2026-Solicitation Review
Dec 23, 2026-Solicitation Review End Date
Requirements
Master's degree
Scored
  • Minimum 3 references
Documents
TitleDate Posted
rfp090326pSep 03, 2026 10:21 AM
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