​Our Regulatory Surveillance and Compliance PMO functions operate as an intelligent governance layer across all study activities.

​

What’s Included

• Real-time monitoring of GxP, ICH E6(R3), and local regulatory standards.

• Continuous audit preparedness — all documentation tracked and time-stamped through cintl.ai.

• Global alignment of study procedures with regional frameworks (FDA, EMA, MHRA, ANVISA, PMDA).

• Automated policy updates and regulatory intelligence alerts.

• Management of pre-approval inspections (PAI), CAPA planning, and compliance closure.

 

How CiNTL Pharma Adds Value:

• Agentic compliance surveillance automatically detects deviations and flags procedural gaps before audit findings occur.

• Cross-functional dashboards provide a single, validated audit trail — fully compliant with 21 CFR Part 11 and Annex 11.

• Our PMO integrates regulatory intelligence into operational planning, ensuring every milestone meets global submission standards.

​​

​Outcome      ​A living compliance ecosystem that protects reputation, minimizes risk, and shortens                                   regulatory response cycles.

 

​