ACTD & CTD Dossier
Comprehensive regulatory dossier preparation for global pharmaceutical market registrations.
Our in-house regulatory affairs team prepares ACTD (ASEAN Common Technical Document) and CTD (Common Technical Document) submissions tailored to each target authority — from Module 1 administrative information through Module 5 clinical study reports.
Markets we cover
ASEAN, MENA, CIS, LATAM, Africa, SADC and selected EU member-state submissions. Our format library and country-pack templates accelerate authoring and reduce response cycles.
Lifecycle services
Initial submissions, variations (Type IA / IB / II), renewals, site master files, country-specific labeling, pharmacovigilance system master files and post-approval change management.
What's included
- Module 1–5 authoring with cross-referenced narratives
- Variations and renewal management
- Site Master File (SMF) preparation
- Country-specific labelling and SmPC writing
- Submission tracking and authority correspondence
Tell us about your market — we'll respond in one working day.
From a single SKU enquiry to a full contract manufacturing partnership, our commercial team is ready with prices, dossier samples and lead times.