These compliance services are designed to ensure organizations meet stringent regulatory requirements while optimizing quality and operational efficiency.

Regulatory Compliance Audits

  • Regulatory Audit and Strategy Development

  • Pre-Approval Inspection (PAI) Readiness Assessments

  • Labeling & Advertising Compliance

  • Regulatory Intelligence & Update

  • Creation and Review of Standard Operating Procedures (SOPs)

  • Quality System Development and Implementation

  • Regulatory Submission Support

    1. Investigational New Drug (IND)

    2. New Drug Application (NDA)

    3. Biologics License Application (BLA)

    4. Market Authorization Application (MAA)

Documentation and Policy Development

Compliance & Quality Assurance

Good Manufacturing Practices (GMP) Compliance

  • Audit & Inspection Readiness

  • Post-Audit Corrective Action Plan Development

  • Deviations and Corrective and Preventive Actions (CAPA) Program Development

  • Data Integrity & Documentation Control

Training & Development

GMP and Regulatory Compliance Training

  • Data Integrity and 21 CFR Part 11 Training

  • Customized Compliance Workshops

Product Safety &

Pharmacovigilance

Adverse Event Reporting

  • Risk Management Plans (RMPs)

  • Post-Marketing Surveillance & Safety Monitoring

Data Integrity Compliance

Assessments for Data Integrity Vulnerabilities

  • 21 CFR Part 11 Compliance Assessments

Quality Management System (QMS) Compliance

Design, Implementation, and Maintenance of QMS

  • Continuous Improvement Initiatives for Compliance Standards