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服务
监管专业经验
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。