Ragav B
Country Head and Senior Director @Freyr Solutions
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WORK HISTORY
Country Head and Senior Director @Freyr Solutions
ON, CA
EDUCATION
University of Madras
Master of Business Administration - MBA
University of Madras
Bachelor's degree
University of Madras
Master's degree
ABOUT RAGAV B
Over 15+ years varied experience in IT Industry as SME, Senior Regulatory Associate and Tester in pharmaceutical software domain.• Core competency in pharmaceutical regulatory compliance, requirement elicitation, UAT, business analysis, technology services, team management.• Elected consultant by LIQUENT Inc and Novartis for electronic submission/publishing services.Specialties: US-FDA, Health Canada submissions procedures - ANDA, DMF, NDA. European (EMEA/NA) submissions procedures- eCTD/NeeS - CP, DCP, MRP, NP. Paper based submissions for semi and non-regulated markets.Package Leaflet Preparation: Annotated side-by-side comparison of container label for FDA submissionAnnotated side-by-side comparison of package leaflet for FDA submissionStructured Product Labeling (SPL) for US FDA, SPL-PLR, R3 to R4, Art Work Preparation (Label, Foil, Carton)
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