Pharmaceutical Dossier Preparation Services
Regcure Pharma provides expert dossier preparation services for pharmaceutical regulatory submissions. Our team prepares CTD, eCTD, and ACTD dossiers aligned with international regulatory requirements including ICH, EMA, FDA, and ASEAN guidelines.
We support pharmaceutical companies with complete regulatory documentation, technical writing, formatting, and compliance checks to ensure smooth product registration and faster regulatory approvals.
A. CTD / eCTD Dossier Preparation
We develop complete CTD/eCTD dossiers aligned with ICH, EMA, FDA, and global regulatory standards.
Our support includes
- Module 1–5 compilation and technical writing
- Quality documentation for API and Finished Product
- Stability, validation, analytical data organization
- SmPC, PIL, labels, and artwork preparation
- Country-specific formatting and compliance checks
Each dossier is optimized for faster evaluation and reduced regulatory queries.
B. ACTD Dossier Preparation (ASEAN)
We create ACTD dossiers tailored for ASEAN submissions, ensuring:
- Accurate preparation of Parts I–IV
- Updated MoH/ASEAN formatting and justification notes
- Quality summaries, validation documents, and labeling content
- Streamlined structure to minimize review cycles
Designed to meet country-specific expectations for smooth, timely approvals.