Dossier Support
We specialize in comprehensive dossier preparation services, including CTD, ACTD, and country-specific formats. Our team ensures your documentation meets international standards for smooth regulatory submissions.
DMF Services
We provide detailed Drug Master File (DMF) compilation and gap analysis, identifying missing elements for regulatory submissions in global markets.
Comparative Dissolution Profile
Comparative dissolution profiles are critical for ensuring bioequivalence, as they provide a direct measure of how drug release characteristics influence therapeutic performance across formulations.
Market Dossiers
Approved dossier arrangements for Rest of World (ROW) and emerging markets, streamlining submissions and accelerating product launches.
Bioequivalence Studies
In-depth support for both paper-based and original bioequivalence (BE) studies, ensuring your products meet international regulatory standards.
Technical Documentation
End-to-end documentation support including AMV, PSUR, and in-house validation reports. We ensure precision, compliance, and clarity.