As part of its mandate to support the evaluation and strengthening of national regulatory authorities (NRAs) in the Region, PAHO uses the WHO Global Benchmarking Tool (GBT) as the standard methodology for regulatory systems assessment. The Laboratory Testing (LT) function—one of nine regulatory functions assessed by the GBT—covers activities ranging from sample reception and testing methods, through quality management and equipment management, to reporting and decision-making. Supporting NRAs and national quality control laboratories (NQCLs) in progressing along the GBT maturity levels—and, where appropriate, pursuing WHO prequalification or international accreditation—is a priority under PAHO's regional regulatory strengthening mandate.

IMT/QR's work in this area is guided by the PAHO Regional Policy for Strengthening National Regulatory Systems (CSP30.R12), which calls on Member States to strengthen the laboratory function as part of integrated regulatory systems, and to engage with international harmonization standards. It also aligns with the mandate to support laboratory networks and collaborative initiatives with strategic partners including UNODC, USP, WCO, WHO, WOAH, Interpol, and academic laboratories.

To advance this agenda, IMT/QR requires the services of a professional with specialized expertise in QCL operations, the GBT LT function, and regional capacity-building strategies.

2. General Objective

To provide specialized technical cooperation to strengthen national and regional quality control laboratories (QCLs) for medicines, vaccines, and other health technologies within the framework of the WHO Global Benchmarking Tool (GBT), contributing to improvements in regulatory maturity, the development and implementation of Institutional Development Plans (IDPs), and the articulation of regional initiatives on reliance, capacity-building, and laboratory networks — in alignment with CSP30.R12 and PAHO's BWP Outcome 2.3.

3. Specific Objectives

• Support the diagnosis and identification of focal points for a regional Network of Quality Control Laboratories, with a view to strengthening the Laboratory Testing regulatory function across Member States and fostering collaboration, information exchange, and mutual capacity-building among participating laboratories.
• Support NRAs in the Region in assessing and strengthening the Laboratory Testing regulatory function under the GBT framework, including gap identification and the design of corrective and preventive actions.
• Support the implementation of the laboratory components of Institutional Development Plans (IDPs) in prioritized countries.
• Contribute to strengthening the QCL’s involvement in, and contribution to, other regulatory functions, including but not limited to marketing authorization, vigilance, lot release, market surveillance and control, and regulatory inspections, in accordance with international standards.
• Facilitate the establishment and functioning of regional technical working groups: (i) to advance recognition and/or reliance on laboratory decisions, data, pharmacopeia standards, and information from other NQCLs and regional or international institutions; and (ii) to develop capacity-building resources for QCL staff under PAHO’s REGTEC learning itinerary.
• Strengthening collaboration with regional laboratory networks and strategic partners, including UNODC, USP, WHO, WCO, WOAH, Interpol, and academic laboratories.
• Contribute to the planning, monitoring, and reporting of technical cooperation activities in the area of quality control laboratories, within the framework of donor-funded projects and the IMT/QR program of work.

4. Scope of Services

The consultant will carry out the following activities, organized into six functional areas:

4.1 Regulatory Strengthening and GBT assisted self assessments

• Support NRAs in strengthening the Laboratory Testing (LT) function under the GBT, including gap diagnostics, evidence review, and technical accompaniment in the implementation of improvement actions.
• Provide technical assistance for the development, review, and updating of standard operating procedures (SOPs), technical guidelines, pharmacopeia standards, checklists, and laboratory quality management tools aligned with international standards (ISO/IEC 17025, regional and international pharmacopoeias, GBT).
• Support the development and updating of the laboratory components of Institutional Development Plans (IDPs) in prioritized countries, including the definition of phases, milestones, indicators, and resource requirements.
• Support progressive advancement in GBT maturity levels (e.g., ML3 to ML4) by providing technical accompaniment and, where appropriate, assisting in the exploration of pathways toward WHO prequalification or accreditation of national QCLs.
• Carry out or support on-site technical missions to national quality control laboratories (NQCLs), including through twinning programs and peer-learning initiatives.

4.2 Marketing Authorization and other essential functions — Laboratory and Quality Dimensions

• Support NQCL in clearly articulating and documenting, through standard procedures and relevant records, its involvement in and contribution to other essential functions within the national regulatory system (e.g., marketing authorization, market surveillance and control, regulatory inspections, lot release, among others).
• Provide technical expertise regarding the assessment of quality testing of Substandard and Falsified Products to Detecting, preventing, and responding to illegal or fake medical items.
• Provide recommendations and strategies on quality marketing vigilance programs for sampling products.
• Provide guidance to countries regarding Quality claims procedures, SOPs and laboratory testing validations.

4.3 Technical Working Group: Reliance in Laboratory Testing

• The consultant will support the creation, facilitation, and operation of a regional technical working group on reliance in laboratory testing, aimed at promoting regulatory efficiency through the recognition and use of testing results and laboratory evaluations generated by other jurisdictions or recognized reference laboratories.
• Support the design of the working group's structure, mandate, methodology, and action plan, in coordination with IMT/QR.
• Identify and map current reliance practices in laboratory testing across the Region, including enabling legal frameworks, barriers, and opportunities.
• Facilitate the exchange of experiences among countries and with international partners (e.g., USP, WHO reference laboratories, and others) to strengthen the technical foundation for reliance in laboratory testing.
• Support the development of regional technical guidance or recommendations on reliance in laboratory testing, aligned with convergence initiatives and CSP30.R12.
• Coordinate with any existing working group on reliance in marketing authorization and other regulatory functions to ensure coherence and integration of approaches.

4.4 Training Courses and Resources for the Learning Itinerary

• The consultant will support the operation