Consultant Feedback

"I am impressed with his breadth of Regulatory knowledge and experience, as well as the integrity and quality of his Regulatory work. He emphasizes that Regulatory and Compliance should be data driven and the data need to be integral, traceable, and of high quality."
VP Operations, Biotechnology Company
CMC
Our CMC and Manufacturing support provides CMC and Manufacturing support consulting to ensure successful compliance and submissions to all worldwide regulatory agencies. Our consulting support includes:

  • Gap Analysis of all current CMC processes
  • Preparation and review of all CMC sections for regulatory submission
  • Assistance in validation activities related to
    • Facilities
    • Manufacturing Processes
    • Analytical Assays
    • Equipment
    • Computer Systems Validation
    • Validation master plans
     
  • Assistance with the creation of Comparability Protocols
  • Assistance with Technology Transfers
  • Oversight of Contract Manufacturing Organizations
  • Oversight of Contract Testing Laboratories
  • GMP Audits
  • Creation of GMP SOP's
  • Creation of Quality Manuals
  • Creation of QA/QC SOP's