临床试验供应
处于各个发展阶段的生物制药公司 rely on our 专业知识 and broad capabilities to produce the clinical trial drug product supply they need, 当他们需要的时候. Many of our clinical stage customers start with us in Phase I and progress through Phase III and beyond, as 国家授权正规彩票平台 provides agile end-to-end clinical supply manufacturing services through commercialization, 简化客户的监管路径.
依靠国家授权正规彩票平台:
临床试验供应能力
Our experts and facilities are equipped to manufacture clinical supplies as small as 1 kg for oral solid dosage forms with a variety of technologies, 包括:
- 湿法造粒
- 干燥造粒
- 流化床技术，包括溶剂的使用
- 封装
- 平板压缩
- 涂膜
- Stick pack filling — tablets and granules — for pediatric trials
- 液体/悬浮液临床用品
- 栓剂
- 瓶内粉剂(PiB)剂型
专用配方支持
Our formulation experts are your technical resource during every step of your clinical development program. This close partnership and support ensure you receive the best possible advice based on scientific and technical guidance. 从实验台到试验工厂, 达到生产规模的设备, a designated formulator stays committed to your project to ensure continuity and that the knowledge gained through development is maintained for registration and commercial launch.
综合分析支持
Throughout clinical development, we support all your analytical development programs. Our analytical laboratories are equipped with both UPLC and HPLC capabilities, 以及全套的溶解设备. We also provide analytical method validation services for Phase I through commercial. Our stability services cover the entire range of ICH conditions, as well as specialized conditions.
临床试验供应包装服务
从固体到液体再到面霜和软膏, 我们在惠帕尼的设施, NJ和Mirabel, Québec are equipped to meet your clinical study’s unique packaging requirements. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.
