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CMC Regulatory Requirements Database Partner RFP

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RFP Number: SOL1169381
Open Date: January 31, 2017
Proposals Due: April 12, 2017 – 11:59PM (PDT)

Overview

While the pharmaceutical industry and the Global Health community have made great strides in advancing drug delivery to people all around the world, the varying CMC regulatory requirements from country to country and procurer to procurer create a great challenge to efficient development and delivery of medicines. Some of these countries have an evolving regulatory landscape that has increased the complexity and unpredictability of the development and registration process. The difficulty in ascertaining CMC requirements and the differences in these requirements between countries can create barriers to the efficient development and delivery of registered quality pharmaceuticals in one country from reaching people in another country. These challenges also impede pharmaceutical companies from efficiently planning their product development and regulatory strategy pathways, unnecessarily wasting time and resources.

To that end, the Bill & Melinda Gates Foundation is soliciting proposals to develop and sustain a routinely updated CMC regulatory requirements database platform with respect to small molecule medical products. The platform will house a database of CMC regulatory information from specified low and middle income countries, bringing much easier access to this information for product developers, regulators, procurers, and others interested in Global Health. The aim is to establish a long-term, sustainable database of CMC regulatory requirements so that the foundation’s product development partners and others can optimize their product development plans and regulatory strategies, thus accelerating product introduction.

This document is an invitation for proposals for a CMC Regulatory Requirements database partner that will:

  • Translate a preliminary database into an interactive, dynamic, searchable, and user-friendly web-based platform
  • Maintain the database and ensure the information is kept up-to-date
  • Design a financially self-sustaining business model

Timeline

January 31, 2017: Request announced.
April 4, 2017 – 11:59PM (PDT): Deadline for clarifying questions.
April 12, 2017 – 11:59PM (PDT): Deadline for submitting proposals.
June 2017 (TBD): Finalist presentations.
July 2017 (TBD): Award announced.

(Note: grant awards will be contingent on the successful completion of due diligence processes)

How to Apply

Detailed proposal requirements and guidelines can be found here.

To view information about this opportunity and submit an application, follow the instructions below:

  1. Create an account on the Application Portal by clicking here
  2. Start a new application by clicking here
  3. Edit your existing draft application by logging back into the Application Portal and clicking here
  4. If you plan on applying, please notify CMCDatabase@gatesfoundation.org so we know to expect your application

Please note:

  1. The first time you visit the Application Portal you will need to create an account. After you enter your information, a temporary password will be emailed to you. Return to the Application Portal to personalize your password and complete your account profile.
  2. You can save the application and return to it later by logging in at any time before the submission deadline with your email address and password. The in-process application can be found in the “My Open LOIs and Grant Application” section. Click “Draft application for SOL1169381” to edit.

Requirements

To apply, please submit a proposal that includes the attachments listed below:

  • Concept memo describing the proposed project (up to 10 pages, template and guidelines provided)
  • Budget/financial model for the proposed activities
  • Most recent organizational financial statements (audited, if available)
  • Prototype, mock-up, or analog of proposed database platform (optional; will be required of finalists)

 

More Information

For more information about this RFP, please review the RFP Guidelines & Information and FAQ document. For any other questions, contact CMCDatabase@gatesfoundation.org.

 

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