Quality Management System implementation Review of study plan, Raw data and final reportsReview of Method Validation of Bioanalytical and Dose formulation analysisBioanalytical and Dose formulation analysis processing generated data & report reviewPlanning and Execution of Study based, Process based and Facility based inspectionPromptly report any audit findings in writing to Management, Study Director and Head Quality Assurance Post audit compliance verificationReview of SOPs, Method of analysis, Forms and FormatsReview of Qualification document of Instrument, Software validationVendor audits, Contract reviewsReview of microbial analysis report of water, facilities etc.Review of Deviation, Amendments, Change controls and CAPA ManagementPreparation and Issuance of QA statementManagement and Handling of Master and Controlled SOPsControl and issuance of standard forms and logbooksArchiving of QA documentsSupport in Regulatory/External InspectionPre-clinical IND reviews and Regulatory compilation for New chemical entity for regulatory submissionFaced Various inspections like USFDA, National GLP complaince monitoring Authority, NABL inspection

Preparation of protocolPreparation of informed consent formsPreparation of Case record forms for Bio availability/Bio equivalence study and clinical TrialsPreparation of T-Licence for various countriesPreparation of Package inserts/Prescribing information for various countriesPreparation of Bio equivalence study report for various regulatory submissionResponsible for monitoring of various activities with study co investigator during the conduct of the study