REGULATORY ISSUES


  • 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

(55) 7576·2567
info@sypharcon.com


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