LEGAL AND PATENTS
Regulatory strategy and process definition.
Process for obtaining sanitary registrations of drugs and devices.
Review, assembly and submission of files to the Federal Commission for Protection against Health Risks, COFEPRIS.
Strategy for Bioequivalence and Clinical Studies.
Generic products and new molecules.
Planning of audits for GMP of National and Foreign Manufacturing by COFEPRIS.
Design of Quality Control System for analysis of medicines, food products, stabilities and validation of analytical methodologies.
Obtaining a Notice of Operation and Sanitary License.
COFEPRIS pre-inspection plans for Sanitary License.
Registration and processing of new molecules in Mexico.
Development of Import Permits for Medicines and Medical Devices.
Health Responsible, Pharmacology, Distribution Centers, Medical Consulting and Advertising Permits.
Av. México 546 (antes 2), San Jerónimo Aculco Magdalena Contreras, 10400, CDMX
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