Where Expertise and Experience create Excellence!
Quality and Compliance
quality

Companies invest enormous amount of resources (capital, employees and time) to develop drugs and bring them to marketplace. Compliance to regulatory requirements is crucial to obtaining and maintaining approval for manufacturing these drugs. Our expert resources help you with managing various engineering, quality, and compliance activities related to product manufacturing and release.

Our areas of specialty include:
  • Validation Planning
  • Risk Management
  • User Requirements Gathering and Documentation
  • Qualification Protocol (IQ, OQ, PQ) Development
  • Design Validation and Verification Protocol Development
  • Qualification Protocol Execution
  • Validation Reporting
  • Trace-ability Matrices
  • SOP Development and Review
  • Validation Gap Analysis and Remediation
  • Process and Product Validation
  • Equipment Qualification and Commissioning
  • Risk Management
  • Test Method Validation