Anjali Virani Email & Phone Number | BA BE study and clinical trials Professional with 10+ years of experience in Bio study activities including Project Planning, Medical Writing, Regulatory Inspection compliance, Study Initiation, Execution, Monitoring, Team management, CRO evaluation and compliance. • Medical safety inputs while designing study protocols • Key opinion leader for important decision making process for BA BE studies and clinical trials •Well trained on application of good clinical practices ICH E6 (R2) in day to day activities of BA BE studies and clinical trials • Knowledge of USFDA, EMA, CDSCO, Schedule Y, ASIAN and ANVISA guidelines of BA BE studies • Handling of all major regulatory Inspections • Expert in System development and inputs in SOP, CCF. Trained to have CAPA for deviations • User specification requirement (URS) generation, CapEx application, calculation of budget for department, man hour’s calculation and man power budgeting. • Vendor selection for outsourced activities, communication with instrument engineers Reach out to me: Email: anjalivirani@gmail.com

Anjali Virani

BA BE study and clinical trials Professional with 10+ years of experience in Bio study activities in...
Ahmedabad, Gujarat, India

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Anjali Virani’s Location Ahmedabad, Gujarat, India

Anjali Virani’s Current Industry Intas Pharmaceuticals

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Assistant General Manager

Present

Assistant General Manager, Cdma

2023-05-01 00:00:00 - Present

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Anjali Virani is a BA BE study and clinical trials Professional with 10+ years of experience in Bio study activities including Project Planning, Medical Writing, Regulatory Inspection compliance, Study Initiation, Execution, Monitoring, Team management, CRO evaluation and compliance. • Medical safety inputs while designing study protocols • Key opinion leader for important decision making process for BA BE studies and clinical trials •Well trained on application of good clinical practices ICH E6 (R2) in day to day activities of BA BE studies and clinical trials • Knowledge of USFDA, EMA, CDSCO, Schedule Y, ASIAN and ANVISA guidelines of BA BE studies • Handling of all major regulatory Inspections • Expert in System development and inputs in SOP, CCF. Trained to have CAPA for deviations • User specification requirement (URS) generation, CapEx application, calculation of budget for department, man hour’s calculation and man power budgeting. • Vendor selection for outsourced activities, communication with instrument engineers Reach out to me: Email: anjalivirani@gmail.com