Regulatory Services

Regulatory Services

I3infotek Regulatory Services 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 Services 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