1st company and corporate university founded through master’s and PhD level research specializing in International Regulatory Affairs.

Specialized in legalizing manufacturers, importers, exporters, physcochemical and microbiological laboratories.

Specialized in different product categories: medicines, medical devices (IVD/MDR/Software), food (nutraceuticals), cosmetics, saneants, biocides, etc.

We operate throughout the product life cycle, from the regularization of a company to the MHA (approval process of the product). Working with customized projects, in addition to certifying the company and its products, we help our clients to become more competitive and structured companies to face the new regulatory challenges in different countries, always respecting good compliance practices.

Its differential is to offer its customers a technical, regulatory, institutional and personalized marketing strategy at the global level (EMEA, North America, Latin America, APAC, MENA and UK) considering the entire chain involved in order to ensure the compliance of the company.

Through Regulatory Intelligence and of the metodology that we developped last years, we are able to monitor, track and provide information on trends, enforcement actions, regulations, standards, guidance and directives impacting our Clients product in the areas of pre-market submission, registration requirements, post-market surveillance, price registration.

Our professionals and professors are homologated and legalized to work in different countries. Providing greater safety and robustness for our customers, since proof of technical qualification is mandatory in different inspection and/or audit processes.