A pharmaceutical quality assurance professional with 20 years of diverse and comprehensive experience in GCP, GLP, cGMP activities of drug development for IND to Phase 1 to 3 clinical trials and Bioequivalence studies. Mahesh has worked with various National and International Pharmaceutical and Biotechnology companies viz. Nektar, Pliva (now Teva), Aizant, Torrent, Sun Pharma, Aristo at various levels including global roles ranging from Bench level scientist to Head QA Positions. Prior to establishing ClinTAsk, Mahesh has worked with Nektar in the capacity of leadership role as Head QA for Nektar India site and  also has lead the QA for bioanalytical department at Nektar San Francisco USA site. During his career he had set up quality systems for 2 BA/BE centers  in India and 1 Bioanalytical lab for clinical trails in San Francisco, USA. Mahesh had a proven record of accomplishments in the implementation of successful Inspection Readiness (IR) programs and successful management of regulatory inspections leading to positive outcomes in inspections conducted by USFDA, EMA,ANVISA, WHO, MoH Turkey, DCG(I), OECD GLP, ISO 17025, ISO 15189. Mahesh has hosted/faced about 40 regulatory inspections and approx. 200 sponsor audits for GCP/GLP/cGMP. Conducted 12 third party site audits for GCP/GLP/cGMP.  Mahesh has extensive experience in Computer System Validation of Combined instruments and stand-alone applications at user end like MasterControl eDMS, Veeva eQMS, ComplianceWire eLMS, Watson LIMS, eLN,  Empower Software, Analyst Software.