Thirteen bilingual documents, organised in the order a regulatory reviewer reads them. Send the index page as a link with your first email — not as attachments.
十三份中英双语文件，按法规审评人员的阅读顺序编排。首封邮件附上索引页链接即可，不必塞附件。
Status: templates pending the manufacturer's signed originals.
The documents below are formatted templates prepared for the Unibest excipient range. Fields shown as [ to be confirmed ] must be completed from the manufacturer's stamped files before the pack is sent to a customer, and any document described as a declaration or certificate must be issued and signed by the manufacturing site.
状态：模板，待工厂签章正式版替换。
以下文件是为 Unibest 辅料产品线准备的标准格式模板。标注为 [ 待确认 ] 的字段，须由工厂正式盖章文件补齐后方可对外发送；凡属声明或证书性质的文件，必须由生产场地出具并签章。
A first email with eighteen attachments is filtered as spam before a human ever reads it. Send the index page as a link, and add the document the buyer's question actually needs.
带着十几个附件的第一封邮件，在被人读到之前就已经进了垃圾邮件。把索引页作为链接发出，再按对方的问题补一份具体文件。
| Item项目 | Replaces替换文件 | Status状态 |
|---|---|---|
| Excipact / SGS cGMP certificate证书 | 01 | Pending |
| Manufacturing licence生产许可证 | 01 | Pending |
| NMPA registration certificate注册证明 | 01 | Pending |
| BSE/TSE statement声明 | 02 | Pending |
| Residual solvent statement残留溶剂声明 | 02 | Pending |
| Elemental impurity risk assessment元素杂质风险评估 | 03 | Pending |
| Nitrosamine assessment亚硝胺评估 | 03 | Pending |
| Batch analysis & stability data批检验与稳定性数据 | 07 | Pending |
| DMF filing proof备案证明 | 08 | Pending |
| GMO-free / Halal / Kosher | 09 | On request |
Once the factory files arrive, replace the corresponding PDF in /downloads/ keeping the same filename — every page link stays valid.
工厂文件到位后，用同名文件替换 /downloads/ 下对应的 PDF 即可，站内所有链接无需改动。
Tell us the market and the dosage form. Additional declarations, translated CoAs and site questionnaires are prepared on request.
告诉我们目标市场与剂型。可依需求提供额外声明、翻译版 CoA 与场地问卷。
