CTD/eCTD Submissions

We offer comprehensive solutions to help you to easily create files that comply with the latest regulatory rules.

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Is this your challenge?

The main challenge for many pharmaceutical companies is to find specialized professionals that have years of experience in the field, understand the structure and format of CTD/eCTD documentation, have the ability to translate highly technical content, and are able to deliver the translations within rigorous deadlines.

How can CSOFT Health Sciences Help?

Quality and Efficient Translations

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Professional linguistic team with a rich pool of knowledge in regulatory, medicine, chemistry, and physics
16+ years of experience of precise translation for Module 2, 3, 4, 5 including CMC, PK/PD, Toxicology, Clinical Written, and Tabulated Summaries
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Technology-driven systems to ensure terminology accuracy and compliance with the latest regulations
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Total cost-effective solutions that promise on time delivery

Regulatory-Compliant Formatting

  • Hypertext, index, and bookmark creation to ensure document cross-references
  • Internal Hyperlinking – Sections, Tables, Figures, References, and Appendices
  • Table of Contents – Overall, Tables, Figures, and Appendices
  • Embedded Fonts
  • Consistent Headers/Footers and Page Orientation
  • Converting PDF documents into MS Word files through OCR (Optical Character Recognition)

Our Methodology

CSOFT International has a 10,000+ strong network of industry- experienced linguists, professional in-country reviewers, cultural experts, and DTP engineers that are ready to deliver localization solutions for regulatory submissions at any time.

CSOFT is specialized in CTD translation projects. Our professional team has in-depth knowledge of recent NMPA policy reforms and regulatory requirements. We have quality control methodology for dossier translations designed for helping new global drug developers mitigate risk while seeking approval from global regulatory bodies.