Kartik Koshti

Scientist - Ii (Executive Trainee) @Torrent Pharmaceuticals Ltd

Ahmedabad, IN

Feasibility assessment/ new product evaluation• Literature review• BA/BE Study designing• Review of BA/BE study documents i.e. clinical study report, ICF, protocol, CRFs, etc.• Preparation of documents for regulatory submission (i.e. BENOC, Import license application etc.)• Handling of investigational products and non-investigational material• BE study monitoring (as per GCP & GLP)• Preparation of BE study monitoring visit report• Establishment and maintenance of study documents (i.e. Sponsor Trial master file)• Document preparation for dossier submission (i.e. Clinical overview, Non-clinical overview, Summary tables (DBE), etc.)• Technical support to FnD, ADL, Quality, PDG, Plant, etc.• Response to regulatory/customer queries• Preparation/review of medical write-up (i.e. medical risk assessment, product development rationale, safety updates/PSUR summary in co-ordination with Pharmacovigilance, MSDS, etc.)• Co-ordination for Serious Adverse Event reporting• Support marketing team• Technical support to team present at international locations

NIPER Guwahati

M.S PHARM, Pharmacology and Toxicology

PEARL PUBLIC HIGHER SECONDARY SCHOOL, SAGAR, (M.P.)

12th

Dr. Harisingh Gour University (Sagar University)

Bachelor's of Pharmacy, Department of Pharmaceutical Sciences

PEARL PUBLIC HIGHER SECONDARY SCHOOL, SAGAR, (M.P.)

10th