Pharmaceutical CTD Module Translation Program
Translated CTD Modules 2/3 quality and clinical summaries for ANDA and EU DCP filings for a generics company.
Contexto
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.
Resultados
Filing agent confirmed translated files ready to mount in eCTD structure
Servicios:
Idiomas:
Retos del proyecto
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.
Nuestro enfoque
Entrega por fases equilibrando calidad, cumplimiento y plazos.
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.
Entregables
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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