ABOUT GARDP FOUNDATION

The Global Antibiotic Research & Development Partnership (GARDP Foundation) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).

GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.

Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.

As of 2024, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.

PROJECT BACKGROUND & PURPOSE OF THE RFP

Background to project

The Global Antibiotic Research and Development Partnership (GARDP) is seeking a qualified service provider to manage and maintain its electronic Regulatory Document Management System (RDMS). The RDMS is utilized for managing and archiving electronic Common Technical Document (eCTD) files/dossier and other regulatory documents related to drug submissions to regulatory authorities. The service provider will be responsible for conducting all activities in the RDMS and hosting the RDMS in a centralized database on their platform. It is important to note that there will be no authoring, reviewing, or publishing of documents within the RDMS. GARDP staff will have user access to view and download documents from the RDMS. Beginning in 2025, one molecule submission will be initiated, and the service provider will be responsible for storing eCTD file/dossier and other regulatory documents for three countries, with plans to extend this to additional countries over the coming years. The marketing authorization holders (MAHs) will share the dossiers and other regulatory documents submitted to regulatory authorities with GARDP. These eCTD files/dossiers and documents from the MAH will be stored on this platform for access by GARDP users. It is important to note that GARDP is not a marketing authorization holder and currently has no plans to submit eCTD files/dossiers and documents to regulatory authorities. This platform serves solely for the viewing, storage and archiving of dossiers and regulatory documents submitted by MAHs, who are sublicensees to GARDP.

Purpose of RFP
Objectives:

1. Secure Storage: Ensure all eCTD dossier submissions and regulatory documents (CPPs, registration certificates, etc) are electronically stored securely, with robust access controls and data encryption.
2. Compliance: Maintain compliance with all relevant regulatory requirements, including FDA, EMA, and other global health authorities.
3. Accessibility: Provide easy access to view and/or download eCTD dossier submissions and other regulatory documents for authorized personnel anytime, with user-friendly interfaces, search and report functionalities.
4. Support and Maintenance: Offer ongoing training, support and maintenance for all activities on the RDMS and to ensure the system remains up-to-date and functional.

SCOPE OF WORK

Services Required

1. Regulatory Document Management System (RDMS):
   1. Implementation of a secure, compliant electronic RDMS tailored to GARDP’s needs on the service provider’s platform.
   2. Conduct and manage the storage, retrieval, and archiving of eCTD files and other regulatory documents.
   3. Ensure proper version control and document integrity.
2. Data Migration:
   1. Secure migration of existing eCTD submissions and other regulatory documents from GARDP database to the RDMS.
   2. Verification of data integrity post-migration.
3. Compliance Documentation:
   1. Documentation demonstrating compliance with regulatory requirements.
   2. Regular compliance audits and reports.
   3. Documentation of all system updates and changes.
4. User Support:
   1. Training for GARDP staff on the use of the RDMS.
   2. Offering ongoing support and assistance to ensure efficient use of the system
   3. Regular system updates and maintenance.

DELIVERABLES

• Implementation of the RDMS
• Monthly performance and maintenance reports.
• Updated system documentation and user manuals.
• Training materials and session records.
• Audit and compliance reports.

CRITERIA FOR SELECTING SUPPLIERS

The decision to award any contract as a result of this RFP process will be based on Suppliers’ responses and any subsequent negotiations or discussions. The decision-making process will consider the ability of each supplier to fulfil GARDP Foundation’s requirements as outlined within this RFP and the total cost of the offer.
Proposals will be assessed against, but not limited to, the following criteria:

Technical criteria
Technical criteria will weigh a maximum of 70% of the award decision. They include technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit.

Financial criteria
Financial criteria will weigh a minimum of 30% of the award decision. They include supplier competitiveness and the completeness of the offer, payment schedule based on deliverables, and a special discount for not-for-profit organizations.

Proposals evaluation and bid defense meeting
Based on a pre-aligned selection grid, the GARDP Foundation selection committee will evaluate all written proposals to determine which suppliers shall be invited to a virtual meeting with the GARDP Foundation selection committee.
The duration of each meeting will be around 1 hour, including follow-up questions and answers. Agenda and potential questions will be shared in advance, together with the invitation to participate.

Value-add and insight
Please list/describe any additional services that you feel would benefit GARDP Foundation and their associated costs (if any).

Data privacy
GARDP Foundation is committed to protecting and respecting your privacy in compliance with the European General Data Protection Regulation (GDPR). Our Privacy Notice (Annex 3) sets out the basis on which the personal data collected from you, or that you provide to us, will be processed by us in connection with your relationship with GARDP Foundation, as vendors, suppliers or third parties. By responding to our RFP, you confirm that you have read our Data Privacy Notice and confirm your understanding on how your personal data will be stored and processed by GARDP Foundation.

If you are interested to participate, please send a request to: RFP_Procurement@gardp.org to receive complete documentation of this RFP

Due/closing date: February 10th 2025