Tribis Inc Regulatory Affairs and Quality Assurance team provides global regulatory and auditing services to the pharmaceutical and biotech industry. We understand the need to maintain 100% compliance with industry regulation and guidelines.Our Regulatory Affairs and Quality Assurance services include:

  • Regulatory Strategy
  • Formulation and Review of Product Applications
  • Briefing Document Preparation
  • Label Development and Review
  • Investigative Site Audits
  • GMP/GLP/GCP AuditsDue to the criticality of balancing regulatory needs with internal efficiencies, organizations are taking a more comprehensive view of compliance. Our Validation and
  • Regulatory Compliance consulting practice provides services in quality systems and compliance, and can assist your organization with a range of needs including compliance with
  • regulations such as 21 CFR Part 11.Our Compliance services include:
  • Clinical Study Compliance
  • 21 CFR Part 11
  • HIPAA
  • Sarbanes-Oxley
  • Compliance and Quality Systems