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 be able to deliver the translations within rigorous deadlines.

How CSOFT Life Sciences can help?

Quality and Efficient Translations

devices

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

biotech

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 reviewer, 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.

Contact us for more information

xxx@csoftintl.com
+1 (888)888-8888

Other Medical Translation Services

CONTACT US

info@medl10n.com

+1-415-889-8989

US Headquarters

580 California Street, Suite 1330
San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F
No.1 East Third Ring Road
Beijing, China 100020

Europe Headquarters

Neumannstraße 10
40235 Düsseldorf

 

Contact us directly

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North America Headquarters

580 California Street, Suite 1330 San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F No.1 East Third Ring Road BeijingChina 100020

European Headquarters

Neumannstraße 10 D-40235 Düsseldorf, Germany