PROAMYE is a highly specialized and multidisciplinary firm which offers services related to Sanitary Regulation regarding the Mexican Regulatory Authority: COFEPRIS.
We provide consulting and management services in the Regulatory Affairs Area. We keep our clients informed on time about Regulations and Regulatory changes, that must be observed by manufacturers, suppliers and importers among others, for activities that are related to the manufacture, distribution and sale of Medications, New Molecules, Products based on Cannabis and its Pharmacological Derivatives.
We provide advice to national and foreign manufacturing laboratories to obtain the Sanitary Registration before COFEPRIS of yours Supplies for Health, and Sanitary License for the Establishment, which will allow them to manufacture, market and / or distribute their products in Mexico and abroad.
Our experience in advising and managing procedures of Health Supplies before the Mexican Regulatory Authority COFEPRIS, facilitates the administrative and operational processes of our clients.
Our mission is to support you to manage effectively before COFEPRIS and other regulatory bodies in México, all kinds of procedures for the optimal functioning of your establishment and proper sanitary regulation of your Health Supplies.
Providing Professional Services of Advisory and Management highly specialized in the field of Sanitary Regulation of Health Supplies: Medicines, new Molecules and Products based on Cannabis and its Pharmacological Derivatives.
Companies, Physical Persons with Business Activity, Professionals in the Health Sciences Area, and Public in general that require to manufacture, market, store, import and export:
• Generic Drugs.
• New molecules.
• Products based on Cannabis and its Derivatives Pharmacological.
That they must comply with current regulations in Mexican legislation and that they require advice, support, specialized coordination, outsourcing and management before regulatory bodies such as COFEPRIS.