Quality Management System

We offer technical and quality expertise, ensuring cGMP compliant testing is conducted, supporting you in navigating the regulatory path for your product. Built upon years of experience, our Quality System is optimized to meet technical and regulatory requirements in an efficient manner.

  • Quality policies and Quality Manual
  • Standard Operating Procedures (SOP’s)
  • Validation Master Plan
  • Sample management
  • Deviation management
  • Calibration and Preventative maintenance
  • Change Control
  • Document Control
  • Incident management
  • Risk management process
  • Training management
  • Organizational roles and responsibilities

Knowledge Management

We manage process and product knowledge throughout development.

Our information systems safely store your data and comply with requirements of regulatory and intellectual property agencies.

  • Laboratory notebooks
  • Standard operating procedures (SOPs)
  • Process History Files
  • Analytical History Files
  • Data Recording Forms
  • Stability reports