ACTD

To become a Research-based International Regulatory Affairs and dossier development center

ACTD is a critical document for drug products and produces registration in ASEAN region. The document is essentially divided into 4 parts.

We Prepare, Review & Submit ACTD dossiers.

Part I – Administrative Information and Product Information

Part II – Quality (S part – DMF & P Part – Finished Product)

Part III – Nonclinical Study Reports (Literature-Based)

Part IV – Clinical Study Reports (Literature-Based)