背景
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.
成果
Filing agent confirmed translated files ready to mount in eCTD structure
サービス内容：
対応言語：
プロジェクトの課題
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.
アプローチ
品質、コンプライアンス、納期のバランスを取った段階的納品。
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.
成果物
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.