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 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.