Venkatesh Koppula

Team Leader @Viatris

Bengaluru, IN

Analytical method development for Injectable formulations i.e Liposomal injections, Microsphere formulations, Iron complex formulations and Peptides.Analytical method evaluation of API against with vendor MOAs and optimization of methods.Method equivalence testing.Validation of analytical methods for the intended purpose and Method transfer to the Commercial plants and preparation of protocols, validation report.Analytical services to the FD and Commercial plant support.Hands on experience with NDDS/Complex formulations like Microspheres, Liposomes, Injectable Suspensions and Peptide molecules etc.Handling of Incidents, Root cause with Investigation tools, change control and CAPA etc.Knowledge about ICH and cGMP guidelines and Drug Regulatory complains. Participation of certifications courses in Drug dossier preparation, CTD, eCTD, DMF (M4 : CTD Modules 1 to 5) and Post approval changes.Document, data review and compilation of various studies of Compatibilities and Stability. Hands on experience of analytical instrumental techniques like HPLC, UPLC, UV Spectrophotometer, Malvern Zeta sizer, Differential Scanning Colorimeter (DSC) and Nano DSC.Life cycle management of instruments.Review and compilation of Drug dissolution profile by Dissolution Apparatus (USP Apparatus I, II & IV), Bottle Rotating Apparatus etc.

Malla reddy college of pharmacy

Master of pharmacy

RGR Siddhanthi college of pharmacy

Bachelor of Pharmacy (B.Pharm.)