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Mahesh Kulkarni founded the QualiCulture Consulting Group in 2016 to provide the consulting services for addressing the issues of Pharmaceutical, Biotech and Medical Device firms around regulatory enforcement (Warning Letter and Import Alerts), regulatory responses, sterility assurance, inspection readiness, leadership, team building, capability building, onsite support for remediation and investigation of discrepancies / non-conformities. QualiCulture offers sustainable solutions to prevent and resolve compliance problems in the following areas to stay current with the ever-changing regulatory and technical environment, as well as with evolving industry practices. 

  • Inspection Readiness - Mock Audits, SME readiness

  • Shop - Floor Compliance Verification

  • Response to Regulatory Inspectional Observations

  • Remediation for Organizations under Regulatory Enforcement and Outstanding Compliance Issues

  • Aseptic Processing - Microbiology and Sterility Assurance

  • Review and Assessment of Laboratory Controls

  • Review and Assessment Submitted Regulatory Application (Approved and Pending for Approval) - ANDA / DMF / IND /NDA