Regulatory Affairs & Registration Dossier Support
Navigating the product registration guidelines of international Ministries of Health (MoH) is one of the most critical aspects of global pharmaceutical imports. AQUA Overseas LLP provides comprehensive documentation support, compiled by an experienced Drug Regulatory Affairs (DRA) team.
Our Regulatory Documentation Services
Dossier Preparation
Compilation of product dossiers in CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document) formats.
Certificates & Legalization
Providing Certificate of Pharmaceutical Product (CoPP) in WHO format, Free Sale Certificate (FSC), and coordinating document verification with local chambers and consulates.
Stability & Chemistry Data
Providing real-time and accelerated stability analysis data aligned with climatic Zone IVa and Zone IVb parameters.
Bioequivalence Studies
Sharing bioequivalence study data and clinical trail profiles for registration clearance of generic therapeutics.
