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Regulatory Affairs
Regulatory Affairs
We are recognized for providing regulatory services that meet the highest quality standards and ensure successful regulatory management of the entire product life cycle, from registration to maintenance after authorization and renewal. We have a highly specialized and updated team, whose experience includes the management of regulatory projects for products manufactured in countries in Asia, Europe, Latin America, North America and Oceania. Therefore, we have been providing the following services till date:
Consulting, auditing and regulatory management for the registration, re-registration or changes in the health registration of pharmaceutical specialties, biological products, dietary products, natural products, medical devices, cosmetic products and health products in our drug regulatory bodies (DIGEMID in Peru, AGEMED in Bolivia, etc).
Consulting, auditing and regulatory management for the registration, re-registration or changes in the sanitary registration of industrialized foods and beverages, food additives and chemical inputs for industrial or professional use in the food safety and food regulatory bodies of our markets (DIGESA in Peru, SENASAG in Bolivia).
Advice on the regulatory management of pharmaceutical establishments: start or restart of activities, expansion of activities, relocation of warehouses and expansion of warehouses, among others.
Advice for the regulatory management of controlled products (psychotropics, precursors and narcotics).
Comprehensive outsourcing of the regulatory affairs department for the management of pharmaceutical products, medical devices and health products.
Regulatory feasibility studies to support decision making regarding market entry, new product introduction, local production or assembly, etc.