A Preferred Partner to More Than 400 Clients That Delivers Best Practices in GCP, GMP, GLP, GDP, PV, REMS and GTP Compliance Audits

ClinAudits offers its client partners turnkey auditing and consulting services from Preclinical through Product Commercialization. Our proven, high-value domestic and international regulatory compliance and auditing services enable pharmaceutical, medical device, biotechnology, tobacco and biologics clients, as well as major academic institutions help to navigate the rigorous scrutiny of FDA and other governmental authorities. Specifically targeting GxP auditing tasks, GxP training, SOP design, creation, revision, project management and IND/NDA/PLA/BLA writing responsibilities, ClinAudits enhances both customer productivity and business process optimization (BPO).

To further reinforce our reputation for objectivity and independence, ClinAudits does not conduct or manage clinical trials.

The ClinAudits portfolio of services also includes best practices in GxP auditing and consulting services for the tobacco industry, targeting quality guidelines and regulation.

Regulatory auditing and consulting services from pre-clinical projects through commercialization and through Phase 4 are provided on a contract basis.

These include:

  • Good Clinical Practices (GCP)- Auditing Services
  • Good Clinical Practices (GCP)- Regulatory Affairs Services
  • Good Clinical Practices (GCP)- Other Services
  • Good Clinical Practices (GCP)- Monitoring Services
  • Good Manufacturing Practices (GMP) Auditing and Service Offerings
  • Good Laboratory Practices (GLP) Auditing and Service Offerings
  • Good Tissue Practice (GTP) Auditing and Service Offerings
  • Pharmacovigilance Auditing
  • Risk Evaluation and Mitigation Strategy (REMS)
  • Good Distribution Practices (GDP)- Auditing and Service Offerings

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