Ganesh Kumar Email & Phone Number

Ganesh Kumar is a RA - SENIOR EXECUTIVE at Bioplus Lifesciences. He possess expertise in sop, v&v, regulatory affairs, gmp, pharmaceutical industry and 6 more skills.

Listed skills include Sop, V&V, Regulatory Affairs, Gmp, and 7 others.

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  Ra - Senior Executive

  Bioplus Lifesciences

  Jun 2011 - Present

   Preparation and compilation of pharmaceutical product registration dossiers for Regulated markets (EU, UK), ASEAN and ROW countries.Compilation and review of all documents forming a part of product registration application, query / additional information handling and providing adequate technical support.Dossier compilation /CTD preparation and SubmissionReview of:Product Development ReportRaw Material Spec/MOA/COAMaster Formula Record, Finished Product… Show more  Preparation and compilation of pharmaceutical product registration dossiers for Regulated markets (EU, UK), ASEAN and ROW countries.Compilation and review of all documents forming a part of product registration application, query / additional information handling and providing adequate technical support.Dossier compilation /CTD preparation and SubmissionReview of:Product Development ReportRaw Material Spec/MOA/COAMaster Formula Record, Finished Product Specification,Finished Product Certificate of Analysis, Finished Product Method of Analysis, Analytical Method Validation Protocol and Report,Analytical Method Transfer Protocol,Process Validation Protocol and Report,Material Safety Data SheetStability study data & stability protocol  TT SubmissionDossier updates and site transfer documents License applicationTest license applicationManufacturing license applicationCOPP application SOP Review Artwork Review Liaison with other departments (AD, FD, RA, QC, and Production) for regulatory requirements & issues. Miscellaneous activities like Maintenance of record of Registration, Re-registration, Dossier summary sheet Stability Study monitoring and Report compilation Review of DMF,CEP Preparation of Site master File QMS activities Show less