Red Ring Binder with Inscription Audit.

Auditing

RiverArk has a dedicated team of expert consultants who have worked on variety of audits within the product developmental domain. Our realm of expertise encompasses:

  • Good Research Practice – (exploratory studies not regulated)
  • Good Clinical Practice (GCP)
  • Good Clinical Practice for Clinical Laboratories (GCLP)
  • Veterinary Good Clinical Practice (vGCP)
  • Good Pharmacovigilance Practice  (GPhvP)
  • Good manufacturing Practice for Investigational Medicinal products (GMP for IMP)
  • Good Distribution Practices within Clinical Research (GDP for CR)
  • Computer System Validation (CSV) for IT systems in Clinical Research

Hands on experience on types of audits:

  • Investigator Site Audits  
  • Clinical process Audits – across all processes; end to end within Clinical Research domain
  • Vendor Audits 
  • Clinical Study Report Audits
  • Trial Master File Audits
  • Phase 1 Unit audits
  • Compounding Pharmacies Audit (for IMP compounding needs)
  • Specialty Pharmacies Audit (for specific highly customized compounding needs)
  • BA/BE Unit Audits
  • For Cause Audits
  • IMP manufacturing facility audit
  • IMP storage and distribution center audit

RiverArk has a team of highly qualified and dedicated GXP quality consultants and auditors that strives to provide valuable, in-depth consulting, auditing, and training to the pharmaceutical, biotechnology, and medical device industries.

With our wide-ranging backgrounds, training, and industry experience, we are well suited to provide the expertise, skills, and objectivity to help evaluate, improve, or build your GXP quality systems and improve your quality compliance.