The Global Regulatory Affairs Department provides the necessary support  to bring a product to a market in alignment with the applicable National Regulatory Authority guidelines.  With ever-changing and diverse regulatory environments, increasing regulatory requirements, and increasing development costs and times, the Global Regulatory Affairs Department ensures regulatory compliance: from product development (research, non-clinical and clinical), to the registration, distribution, marketing and post-market surveillance of regulated products.

Since 2010, the Global Regulatory Affairs Department successfully introduced and maintained the regulatory status of 16 different products including medicines and medical devices in over 90 countries in Africa, Asia, Latin America and the WHO Prequalification Programme. We collaborate with organizations such as DKT International, FHI 360, Grünenthal, IPPF, Kessel Medintim, Medicines 360, PATH, Population Council, Population Services International (PSI), and University of California, San Francisco among others, to make high-quality products available to women worldwide. We also provide regulatory support to organizations and companies that seek to introduce their products globally.

For more information or to discuss a partnership opportunity, please contact Wilberto Robles, wrobles@10.10.40.20.