At a glance
- We work across sectors to accelerate the development and introduction of high-impact health interventions in low-resource settings.
- We support foundation partners in implementing transparent, systematic, and data-driven product development approaches to improve the chances of product success and ensure efficient use of resources.
- We offer tools and approaches that facilitate clinical development, regulatory approval, manufacturing, and delivery.
- We work with low-income countries to strengthen their regulatory systems so innovative, high-quality health products can be more readily developed, approved, and made available.
Our strategy
Our team works with a network of more than 200 experts and leaders across all domains of product development and regulatory approval to help foundation teams and partners advance promising global health products faster, more reliably, and more efficiently. We are embedded in the process from the earliest discovery phase through market introduction and beyond, ensuring better decision-making on product investments.
Areas of focus
We support low-income countries, primarily in sub-Saharan Africa, in strengthening their regulatory systems so innovative, high-quality health products can be efficiently developed, authorized, and made available.
We support low-income countries, primarily in sub-Saharan Africa, in strengthening their regulatory systems so innovative, high-quality health products can be efficiently developed, authorized, and made available.
By promoting harmonized technical standards and streamlined regulatory processes—for example, to align with accredited reference agencies and regionalized procedures—we help accelerate product approvals without compromising rigor. We support regulatory systems that oversee clinical trials, manufacturing, marketing authorization, and post-approval monitoring to maintain safety and reduce the prevalence of substandard or falsified products. Collaborating with partners at all levels, we help build essential, nonduplicative regulatory capacity. We also work closely with foundation teams and their product development partners to create tailored regulatory strategies, from target product profiles through approvals and policy recommendations.
We help foundation partners translate scientific innovations into low-cost, widely available health products by ensuring that formulation, manufacturing, and delivery meet quality, regulatory, and market requirements.
We help foundation partners translate scientific innovations into low-cost, widely available health products by ensuring that formulation, manufacturing, and delivery meet quality, regulatory, and market requirements.
Our support spans the full pharmaceutical development process and includes guidance on promising tools and technologies such as long-acting drug delivery and low-cost manufacturing processes. We also work with the foundation’s country offices to engage health authorities and regional manufacturers in efforts to lower the cost of goods and increase product supply.
We work to increase the chances of clinical trial success by providing expertise in study design, aligning endpoints with goals, and ensuring that trials and other types of clinical research are informative and can have impact.
We work to increase the chances of clinical trial success by providing expertise in study design, aligning endpoints with goals, and ensuring that trials and other types of clinical research are informative and can have impact.
Clinical studies require significant investment and can produce vital information, but not all trials provide robust answers to the questions asked. Poor study design can lead to uninformative results and ultimately bad decision-making, wasted resources, and an erosion of trust between study investigators and subjects. We provide scientific design review of our partners’ proposed study plans so they can get the most useful results as quickly as possible and at the lowest possible cost.
Why focus on integrated development?
Too often, promising products are stalled by high manufacturing costs, inefficient trials, regulatory hurdles, and fragmented delivery systems—delays that waste resources and cost lives. Addressing these risks early is essential to ensuring interventions are viable, affordable, and scalable.
Integrated development helps the foundation make confident, evidence-based decisions earlier in the product development process—saving time, reducing costs, and increasing impact for global health products. By working closely with partners, we aim to improve the likelihood that products succeed both during development and in the market, ensuring resources are used effectively to deliver better health outcomes sooner.
Our team works through two complementary approaches. Our Product Support model partners with foundation teams to reduce production costs, optimize trial designs, strengthen regulatory strategies, and guide portfolio decisions—mitigating obstacles before they threaten success. At the same time, our Systems & Platforms work streamlines regulatory pathways, strengthens pharmacovigilance, combats substandard medicines, and advances innovative delivery platforms. Together, these efforts give every global health product the best chance to reach the people who need it most, faster and more effectively.
