GCP Systems, Quality and Compliance play a vital role within the development and manufacturing of products. Treximo’s GCP and Quality focused consultants can provide the necessary guidance to understand the interpretation and utilization of regulations and overall best clinical practices. Ultimately, this will assist in ensuring the mitigation of risk and overcoming any hurdles presented during the drug development process.

Key Offerings include:

  • GCP Site Auditing (Qualification, Selection, Interim and Cause)
  • Vendor Auditing (CRO, Central Labs, IRBs, Data Management, etc)
  • Clinical SOPs and Quality Manuals
  • Audit Program Strategy Management