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.
- ISO 17100 quality standards
- Professional review workflow
- Multilingual project management
Anonymized case - Languages
- 2
- Words
- 1.2M
- Months
- 4
- Filing pathways
- 2
Background
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.
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
Deliverables
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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