Our Team and Experience

Our team in Argentina is a group of professionals specialized in regulatory consulting services, cGMP training and translations of medical and pharmaceutical technical documents since 1990.

They have prepared and submitted registration dossiers for pharmaceutical, medical devices, nutraceuticals, synthetic and biological products with no deficiencies and record time approvals for companies in Argentina, Uruguay, India, USA, Mexico and Europe.

 They design solid and dedicated regulatory strategies in order to increase the pipeline and annual sales in a short period of time.

The team has provided complete GMP and Risk Analysis training to global medical device and pharmaceutical companies with compliance audits and excellent results.

ANMAT
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Avenida de Mayo 869 (C1084AAD)
Ciudad Autónoma de Buenos Aires
Tel: 54-11-4340-0800/0900

 
The National Administration of Drugs, Foods and Medical Devices (ANMAT) is an agency decentralized from the National Public Administration that was created by decree 1490/92.  It cooperates in the protection of human health by assuring the quality of the products it regulates: drugs, food, medical devices, diagnosis reagents, cosmetic, dietary supplements and household cleaning products. Since its creation AMNAT and its group of professionals and technicians have worked with modern technology in order to efficiently fulfill the process of authorization, registration, standardization, vigilance and monitoring of the products used in the human medicine, food and cosmetic fields.

ANMAT main objective is to guarantee that products at the reach of the public be compliant in terms of efficacy (fulfillment of the therapeutic, nutritional or diagnostic objective), safety (high benefit/risk ratio) and quality (by meeting the citizens’ needs and expectations).

Law 16.463 issued in 1964 is the main law that regulates all pharmaceutical activities in Argentina with its corresponding supplements.