Detailed Services
Where Diagnostics Meets Strategy and Innovation
Differentiators
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100+ years of combined experience across academia, industry, and nonprofit sectors
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Deep understanding of regulatory and quality frameworks across diagnostics, pharmaceuticals, and vector control tools
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Proven success managing global health product portfolios in 50+ countries
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Track record of innovation in low-resource settings and health equity-focused solutions
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Expertise in ISO/GLP compliance, laboratory audits, and donor-funded program execution
Expertise
Diagnostics Systems Development & Deployment
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Development and evaluation of diagnostic technologies for low-resource settings, from concept to market entry, including target product profiles (TPPs), clinical validation, and field deployment.
Regulatory Affairs & Dossier Development
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Strategic guidance and hands-on support for global regulatory submissions (WHO PQ, CE marking, FDA), including dossier preparation, gap analyses, and compliance readiness.
Quality Assurance & Risk Mitigation
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Design, implementation, and optimization of Quality Management Systems (QMS) under ISO 9001/13485/15189/17025, and GLP. Expertise in risk management, incident response, and CAPA in global health product portfolios.
Analytical Sciences & Laboratory Systems
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Advanced method development, product stability testing, and laboratory capacity building. Strengthening of analytical workflows and QA systems in LMIC settings.
Program Implementation & Donor Engagement
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Technical leadership for large-scale health programs (e.g., PEPFAR, TGF), supply chain, procurement strategy, including quality oversight, monitoring and evaluation, and evidence-driven implementation strategies.
Training & Capacity Building
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Customized training modules for QA/QC, regulatory compliance, procurement and supply chain strategy, analytical techniques, and global program operations to support local capacity and sustainability.
Focus
Diagnostics and Product Development for LMICs
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End-to-end support for diagnostic product development, including needs assessment, target product profile (TPP) design, usability studies, and product validation.
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Design and oversight of clinical evaluations of diagnostics in LMIC settings.
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Support for point-of-care and decentralized testing platforms tailored to resource-constrained environments.
Innovation & Market Access Strategy
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Landscape analyses for new product introduction, including competitive positioning and regulatory pathways.
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Health technology assessments to support uptake and procurement.
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Stakeholder engagement strategies (with donors, ministries of health, regulatory authorities, and manufacturers).
Health Program Implementation Support
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Technical leadership and oversight for large-scale global health programs
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Monitoring & evaluation frameworks that ensure quality and accountability in diagnostic product deployment.
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Program design and operational strategy, including supply chain, procurement, Point of Care integration, private sector engagement, network optimization, improving efficiency for initiatives focused on health equity and diagnostic access.
Regulatory Strategy & Dossier Preparation
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Preparation and review of regulatory dossiers (e.g., WHO Prequalification, Global Fund, FDA 510(k), CE marking).
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Regulatory gap analysis and remediation plans for diagnostics, pharmaceuticals, and medical devices.
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Technical writing and data presentation to meet diverse regulatory body expectations.
Quality Assurance & Risk Mitigation
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Quality management system (QMS) design, implementation, and audit preparation under IISO 9001/13485/15189/17025, GLP, and WHO PQ frameworks.
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Risk assessment and incident response systems for large global portfolios (especially donor-funded programs).
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Corrective and preventive action (CAPA) planning and execution.
Analytical Sciences & Laboratory Strengthening
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Development and validation of novel analytical methods, particularly where traditional infrastructure is limited.
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Stability studies and analytical characterization of health products including diagnostics, pharmaceuticals, and vector control tools (e.g., insecticide-treated nets).
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Capacity building for laboratories in LMICs (technical assistance, training, SOPs, and QA systems).
