ABOUT GARDP

The Global Antibiotic Research & Development Partnership (GARDP) accelerates the development and access of treatments for drug-resistant infections. Together with private, public and non-profit partners, GARDP works to preserve the power of antibiotics for generations to come.
GARDP is acting now to counter antibiotic resistance and save lives. Antimicrobial resistance (including antibiotic resistance) is one of the top 10 global health threats. In 2019, nearly 1.3 million people died as a result of drug-resistant bacterial infections, more than HIV (~860,000) or breast cancer (~700,000). If left unchecked, antibiotic resistance may kill as many as 10 million people each year from 2050.

Responding to a global health crisis: the story of GARDP
The headlines in 2015 were alarming. A deadly superbug was spreading in hospitals in Australia. An outbreak of drug-resistant gonorrhoea threatened public health in England. The superbug “NDM-1” had reached 70 countries. The BBC warned, “Antibiotic resistance: World on cusp of ‘post-antibiotic era’.”
For years, the problem had been growing. Even as bacteria were becoming more and more resistant to antibiotics, pharmaceutical companies were exiting the antibiotic development industry. The work had become more difficult and expensive, so now the risks outweighed the rewards. And the antibiotics that were being introduced were not particularly innovative—there had been no new class of antibiotics in about 30 years.
In this context, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance (2015).
To deliver on this plan, GARDP was created in 2016 by the WHO and the Drugs for Neglected Disease initiative (DNDi). Like the WHO, GARDP drives a global response to antimicrobial resistance. Like DNDi, GARDP engages in public and private sector partnerships to research and develop new drugs that fit public health needs.
Following an initial incubation period in DNDi, GARDP was legally established in 2018 as a Swiss foundation (GARDP Foundation). Three years later, in 2021, the Swiss government granted GARDP legal privileges and immunities to facilitate GARDP’s collaboration with others working in the field of public health and in recognition of GARDP’s major role in the fight against antibiotic resistance.

Today, GARDP is a not-for-profit organization with over 50 staff. They are part of the GARDP global network, including GARDP North America Inc., representation in Australia, DNDi-GARDP Southern Africa NPC, the Drugs for Neglected Diseases initiative, and associated DNDi regional offices in India, Japan, South America, Southeast Asia and Kenya.
Together with essential support from donors and key research and development partnerships, the GARDP global network makes it possible to carry out global research and drug development trials, as well as expand access to antibiotics for appropriate use, in close connection with communities around the world.

GARDP R&D strategy for Neonatal sepsis aims at delivering, an affordable ’empirical’ treatment for neonatal sepsis and meningitis in settings with high resistance rates to the WHO first line empiric therapy of ampicillin and gentamicin, where the pathogenic bacteria have not been formally identified. The objective of the GARDP Neonatal sepsis project is to meet the public health needs to identify novel regimens from existing generic antibiotics that provide broader coverage against multi-drug resistant pathogens to improve clinical outcomes for neonatal sepsis globally.

 

PROJECT BACKGROUND

The service provider will assess the investment it would take for GARDP to apply and maintain the Establishment License for Foreign Trade with Swissmedic, according to Art. 18 (1) (c) of the Swiss Therapeutic Products Act (“TPA”). The aim is to quantify the human and financial investment to acquire and maintain such a license. The envisaged scenario is that GARDP acts as a buyer of production batches of its products and resells these batches to distributors. GARDP would not distribute these products to end users.

 

PURPOSE OF THE RFP

To quantify the human and financial investment to acquire and maintain such a license.
To provide a concept on how GARDP could meet the requirements with a minimal investment, including by outsourcing key tasks.

 

SCOPE OF WORK

Initial Consultation and Assessment

• Conduct an initial meeting with GARDP to understand the business operations, scope of foreign trade activities, and specific needs.
• Assess the current state of the organization’s documentation, processes, and compliance with Swissmedic regulations.
• Identify gaps or areas requiring improvement and resources to meet the licensing requirements.

Documentation and Compliance Review

• Review all relevant documents, including organization registration, quality management system (QMS) documentation, Standard Operating Procedures (SOPs), and other necessary documentation.
• Provide a detailed list of required documents and assist in gathering any missing information.
• Ensure all documents are in compliance with Swissmedic’ s guidelines and requirements.

Organization Improvement

• Elaborate and propose an organization-wide setup, which is compliant with Swissmedic’ s regulations and guidelines for foreign trade license authorization.
• Produce an assessment regarding the requirement for a Responsible Person.

Internal Audit and Compliance Check

• Conduct an internal audit to evaluate GARDP compliance with Swissmedic regulations.
• Produce a report detailing any non-conformities and recommended corrective actions.

Minimum experience expected from the Service provider’ representative

• Extensive knowledge of Swissmedic regulations and requirements for foreign trade establishments.
• Proven experience in preparing companies for successful license applications to Swissmedic.
• Strong project management and communication skills.

Responsibilities of GARDP
Make available to the service provider, all necessary documents, data, and resources required to complete the investment assessment for GARDP to apply and maintain the Establishment License for Foreign Trade with Swissmedic.

 

DELIVERABLES

• Initial assessment report outlining the current compliance status and required actions.
• Cost assessment on investment needed (FTEs and financial investment)
• Internal audit report and corrective action plan.
• Final compliance checklist and review report.
• Assessment regarding the requirement for a Responsible Person.

 

CRITERIA FOR SELECTING SERVICE PROVIDERS

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’s requirements as outlined within this RFP and the total cost of the offer.
Proposals will be assessed against the main following criteria but not limited to:

Technical criteria
Technical criteria will weight maximum 70% of the award decision and are composed of criteria such as technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit.

Financial criteria
Financial criteria will weight minimum 30% of the award decision and are composed of criteria such as competitiveness and completeness of the offer, payment schedule based on deliverables, special discount for non for profit organization.

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

Value-add and Insight
Please list/describe any additional services that you feel would be have benefit to GARDP and associated costs if any.

Data Privacy
GARDP 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 at GARDP, as vendors, suppliers or third parties. By responding to our RFP, you explicitly consent to our Data Privacy Notice and confirm your understanding on how your personal data will be stored and treated by GARDP.

 

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: September 30th 2024