Regulatory Compliance Support

Regulatory Compliance Support
I. ADVISORY SERVICES

  • cGMP (current Good Manufacturing Practice) compliance
  • Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
  • Compliance audits as per current and updated statutory pharma regulations
  • GAP Analysis/Due diligence
  • Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms

 

II. TECHNICAL ASSISTANCE

  • Site Master file as per PIC/s & Local FDA requirement
  • Quantitative Risk Assessment ( QRA)
  • Environment Impact Assessment ( EIA)
  • Safety Audits.
  • Energy Audits