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)