WCG has led the registration of more than 16 drug products, medical devices, and cosmetics in 90 countries, including the WHO Prequalification Program
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, medical devices and cosmetics in over 90 countries in Africa, Asia, Latin America and the WHO Prequalification Programme. We collaborate with organizations such as Evofem, FHI 360, Medicines 360, Population Council, Population Services International (PSI), and the University of California, San Francisco to make new, high-quality reproductive health care products available to the women who need them worldwide. We also provide regulatory services and support to organizations with the need to introduce their products abroad.
For more information or to discuss a partnership opportunity, please contact Wilberto Robles, [email protected]