Drug Registration & CTD Dossier Preparation
Drug Registration & CTD Dossier Preparation
At EKOM PHARMEX, we offer expert support in drug registration and Common Technical Document (CTD) dossier preparation, ensuring your pharmaceutical products meet all global regulatory standards.
Our Services Cover:
- CTD/ACTD Dossier Compilation for international regulatory submissions.
- Regulatory Strategy Consulting to align with specific country requirements.
- Preparation of Module 1–5 in compliance with ICH guidelines.
- Coordination with regulatory authorities for smooth approval processes.
- End-to-end support from document preparation to final submission.