Regulatory Services Engagement with Regulatory Tender - 95032844

Procurement Summary

Country: USA

Summary: Regulatory Services Engagement with Regulatory Authorities on Patient-Reported Outcomes (Pros)

Deadline: 26 Jan 2024

Posting Date: 11 Jan 2024

Other Information

Notice Type: Tender

TOT Ref.No.: 95032844

Document Ref. No.: FY24-CIMC-24-01_Consultant_01

Competition: ICB

Financier: Other Funding Agencies

Purchaser Ownership: Public

Tender Value: Refer Document

Purchaser's Detail

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Tender Details

Request for proposals are invited for Regulatory Services: Engagement with Regulatory Authorities on Patient-Reported Outcomes (Pros)
The Consultant agrees to hold the prices in its offer firm for 60 days from the date

specified for the receipt of offers unless another time is specified in the addendum of the

RFP.
Scope of Work

The FHI 360 project seeks a consultant to lead engagement with regulatory authorities around PRO

measures (PROMs) for CIMCs in contraceptive clinical trials, with an initial focus on FDA avenues

for engagement through the various initiatives on patient involvement during drug development

that are outside of pathways regarding a specific contraceptive product (i.e., a specific drug, device,

biologic, or combination product to prevent pregnancy). Examples of these avenues include the

FDA-s patient-focused drug development initiatives within the Center for Drug Evaluation and

Research (CDER) and Center for Devices and Radiological Health (CDRH), including Critical Path

Innovation Meetings (CPIM), the Clinical Outcome Assessment (COA) Qualification Program, and

the Medical Device Development Tools (MDDT) Qualification Process.

Consultant work will include:

• Providing regulatory advice and guidance to the project.

• Preparing and submitting documents to SRAs with project team oversight.

• Attending and/or leading virtual meetings with SRAs, representing the project with project

team members.

• Developing and updating strategies for regulatory engagement on CIMC PROMs.

Example deliverables/milestones include:

• Provide detailed feedback on a regulatory engagement strategy proposed by FHI 360

• Prepare and submit the request for a CPIM to FDA

• Prepare materials for CPIM and submit to FDA

• Lead CPIM

• Prepare and submit Letter of Intent to COA QP and/or Proposal to MDDT Qualification

Process

• Prepare any updated regulatory engagement strategy to FHI 360, as needed

Intended timeline: Q1-Q3 of 2024

Location of Work: The consultant may work remotely from any location with a reliable internet

connection that permits scheduling meetings during normal business hours in the US Eastern time

zone (UTC-5/UTC-4
Timetable and Address for Submission

Proposals are due no later than 5:00 PM EST (UTC-5) on Friday, January 26, 2024. Required

documentation listed below must be e-mailed to [email protected] .
Date of Issue of Rfp: Tuesday, 09 January 2024

Date Questions from Supplier Due: Monday, 15 January 2024, 5pm Est

Date Answers Due from Fhi 360: Friday, 19 January 2024

Date Proposal Due: Friday, 26 January 2024, 5pm Est

Approximate Timeframe Consultant

Agreement Issued to Successful Candidate(S): Late February 2024

Documents

 Tender Notice