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我们的监管团队为您服务
优尼特尔工厂将根据现行的监管要求为您提供CMC专业知识:
- IMPD/INDs的起草,
- 医疗设备(生产部分)的MA文件(模块3和3)以及技术文件的起草,
- 药物变更的起草,
- 回复监管当局的药品问题。
此外,团队将能够为您提供建议,并提出符合监管要求的药品研发战略。