Navakanth Bondalapati
Manager @Dr. Reddy's Laboratories
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WORK HISTORY
Manager @Dr. Reddy's Laboratories
Hyderabad, IN
Labelling:\\\\n Review of prescribing information (PI)/product information, summary of product characteristics (SmPCs), product monograph and patient information leaflets (PILs) to various regulatory authorities\\\\n Preparation/review of Company Core data sheet (CCDS)\\\\n Preparation/updation of PI’s/SmPCs for pharmacovigilance\\\\n\\\\nMedico-Regulatory Documents:\\\\n Review of CTD Modules- Nonclinical overview and summaries (Module 2.4, 2.6 & 4) and clinical overview and summaries (Module 2.5, 2.7 & 5) as per regulatory authority guidelines\\\\n Quality Review of Labels that includes Prescribing Information, Product information, Product Monograph, Summary of Product Characteristics, Patient information leaflets and Consumer Medicine Information\\\\n Preparation of product write-ups, medical rational, nonclinical and clinical documents, bio-waiver justification and literature support to various regulatory markets\\\\n Support to fresh filing via MRP/DCP/National Procedures at European countries\\\\n Answer queries raised by Regulatory Agencies throughout the life cycle of product\\\\n\\\\nSupporting Life Cycle & Portfolio Management Initiatives\\\\n Proposal for Differentiated Products, Super Generics and Super-Super Generics.\\\\n New Product Evaluations\\\\n Medical Rationales for fixed dose combinations, new drug delivery systems, product proposals & generation of target product profile.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
Annamalai University
M.Pharmacy, Pharmacology
Raghavendra Institute of Pharmaceutical Education & Research, Anantapur
B.Pharm
ABOUT NAVAKANTH BONDALAPATI
M.Pharm (Pharmacology) having 13 years experience in Medical writing, Pharmacovigilance and Clinical research
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