GxP Systems, Quality and Compliance play a vital role within the development and manufacturing of products. Treximo’s GxP and Quality-focused consultants can provide the necessary guidance to understand and interpret 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:

  • GMO, GCP & GLP Site Auditing
  • Site Audit Evaluation Services
    • Scientific Faculties and Project based
    • Qualification, Selection, Interim and Cause
  • Pre FDA Audit Preparation & Training
  • Remediation of Regulatory Filings and Documentation
  • Vendor Auditing
    • CRO, Central Labs, IRBs, Data Management, etc.
  • GxP SOP and Quality System Documentation Review and Creation
  • Audit Program Strategy Implementation and Management