CTD Dossiers Preparation

Common Technical Document (CTD) Format Dossiers

We are committed to provide you with compliance and compatible eCTD dossiers on time with high-quality deliverables. The eCTD dossiers will be cost-effective, complete, comprehensive and correct, duly crafted with the therapeutic understanding of the regulatory requirements and the deep therapeutic area expertise. Our eCTD dossiers will meet the specified formats of eCTD requirements.

Our Expertise

  • Marketing Authorization Dossiers Preparation (CTD modules 1 to 5)
  • Translation of Dossier in all Desired Target Languages
  • Reformatting of Existing Dossiers to the Current Formats., eCTD, NeeS or paper dossiers, etc
  • Marketing Authorization Dossiers for Medicinal Products and Diagnostics
  • Common Technical Document(CTD) Summaries