Anonymized case

Pharma & Life Sciences · 4 months

Pharmaceutical CTD Module Translation Program

Translated CTD Modules 2/3 quality and clinical summaries for ANDA and EU DCP filings for a generics company.

Result Filing agent confirmed translated files ready to mount in eCTD structure
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Mutual NDA available on request · Industry QA standards applied

Languages
2
Words
1.2M
Months
4
Filing pathways
2

Background

Industry: Pharma & Life Sciences Timeline: 4 months Languages: Chinese, English Services: CTD translation, Quality summaries, Clinical summaries, etc.

The client is in medtech and life sciences, where filings must align with FDA, EU MDR, NMPA and similar frameworks. “Pharmaceutical CTD Module Translation Program” demands higher precision, traceability and confidentiality than typical business translation.

A generics firm exporting to US/EU needed Chinese R&D and manufacturing materials in CTD English—quality overviews and summaries aligned with pharmacopoeia and ICH guidance.

Linguist assigned industry linguists, reviewers and a dedicated PM. Scope included CTD translation, Quality summaries, Clinical summaries, etc.. Within 4 months, we delivered and QA’d 2 languages—achieving: Filing agent confirmed translated files ready to mount in eCTD structure

Project challenges

  • CTD structure

    Module 2/3 numbering aligned with eCTD mount paths.

  • Pharmacopoeia terms

    USP/EP monograph and test method language.

  • Data integrity

    Batch record summaries and stability data exact.

  • Parallel filings

    Overlapping ANDA and DCP deadlines.

Our approach

Phased delivery balancing quality, compliance and timeline.

  1. 01

    Regulatory alignment

    Confirm target markets, doc types and authority expectations.

  2. 02

    Medical glossary

    IFU/label/clinical glossary and do-not-translate lists.

  3. 03

    Med TEP + DTP

    Medical linguists, second review and layout fidelity.

  4. 04

    Submission packaging

    Organized deliverables per filing templates and change logs.

Deliverables

  • Module 2 summaries
  • Module 3 quality
  • Stability reports
  • Glossary

Project highlights

  • CTD experience

    eCTD mount and section structure.

  • Pharmacopoeia

    USP/EP terminology accuracy.

  • Quality data

    Rigorous test and stability language.

  • Dual filing

    Parallel ANDA/DCP scheduling.

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