Our Team and Experience
The team in Ecuador is composed of professionals (Chemists and Pharmacists), with a vast experience of over 25 years in Regulatory Affairs, Quality Assurance and Compliance with internationally renowned multinational pharmaceutical companies such as GlaxoSmithKline, Grunental, Hoech Eteco, Aventis, Medicamenta, Merck, Ciba-Geigy, among others.
In addition to helping clients with registrations, the team helps with the preparation of an early R&D strategy of the product, conducts and helps with the preparation of Quality and GMP audits related to Pharmaceutical, Medical Device and Cosmetics products
Let us help you be your partners in Ecuador.
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ARCSA
The National Institute of Hygiene and Tropical Medicine "Leopoldo Izquieta Pérez" (INH) was the entity in charge of registration and control of pharmaceutical specialties and medicines. As of August 30, 2012, the INH was replaced by the ARCSA through Decree No. 1290. The "Creation of the National Agency for Regulation, Control and Sanitary Vigilance (ARCSA)" was published in the Official Gazette No. 788. From now on the ARCSA will be responsible for health regulation, technical monitoring and surveillance at national level, therefore in charge of the sanitary registration management. The Agency will also be responsible of exercising the powers in the field of control and health promotion in the terms of the General Law of Health and other applicable provisions. The Agency was established as a centralized administrative body under the Ministry of Public Health. On March 23, 2016, the ARCSA facilities returned to Guayaquil to continue with their health control functions. |