DDReg Pharma

Pharmacovigilance Services in Mexico

Mexico is one of the leading markets for medicinal products and medical devices in Latin America. The Federal Commission for Protection Against Sanitary Risk (COFEPRIS) and National Pharmacovigilance Center (CNFV) is the pharmacovigilance program that oversees adverse drug reactions (ADR) reporting in Mexico from the ADR reports received from physicians, patients/consumers, pharmaceutical manufacturers, and clinical trial conductors. Mexico has a unique pharmacovigilance notification tool called as VigiFlow which allows all the ADR-related data including receiving, processing, and analysis of data to be transferred to the WHO/UMC global database.
As a leading global contender, DDReg understand the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Mexico, we provide end to end pharmacovigilance services that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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