Gain a regulatory advantage with X Pharma Plus CTD dossier templates, meticulously designed for the US and EU markets. Our templates cover a wide range of applications, including INDs, IMPDs, MAAs, BLAs, NDAs, and ANDAs, ensuring your documentation is compliant, accurate, and efficiently organized for successful submissions and faster approvals.
Common Technical Document (CTD) Dossier Services – Overview
Both the US and EU Health Authorities (HAs) require most regulatory applications to be submitted in the ICH-harmonized CTD format. Leveraging a structured submission approach with standardized CTD dossier templates enables efficient regulatory management, accelerated approvals, and cost-effective lifecycle management.
X Pharma Plus provides customized CTD dossier templates for a variety of regulatory applications, including INDs, IMPDs, MAAs, BLAs, NDAs, and ANDAs, tailored for pharmaceutical and biological products.
Common Technical Document (CTD) Dossier Services
“Preparation and submission of standardized regulatory dossiers for pharmaceutical product approval across global health authorities.”
X Pharma Plus CTD dossier templates are designed to streamline regulatory submissions with precision, consistency, and compliance for both pharmaceutical and biological products. Key features include:
Metadata Guidance
User-Friendly Features
Portability
User Guide
Application-Specific Templates
X Pharma Plus CTD templates provide a right-first-time submission approach, significantly reducing administrative rejections, accelerating approvals, and ensuring regulatory compliance across multiple regions and applications.