For research projects requiring GLP compliance, Paragon is prepared in advance with available FDA & OECD GLP-compliant procedures and well-defined deliverables.

For biologics production requiring GMP-compliance, Paragon offers validated systems and processes which facilitate the delivery of bulk API and final drug product for Phase I/II clinical trials.

  • Compliant with applicable regulatory requirements – 21CFR Parts 210 and 211 / ICH Q7A
  • Dedicated project team – GMP-knowledgeable and experienced
  • Utility and environmental monitoring
  • Preventative maintenance and calibration program
    • Ensuring validated systems and equipment are appropriately maintained and operating as defined
  • Materials control
    • Receipt, handling and shipping of raw materials and components, equipment, supplies and product
  • Production and process control
    • Master and batch production records, test methods, and labeling and package control
  • Personnel training and qualification
  • Continuous evaluation and improvement