Regulatory Affairs Consulting Page

提供战略指导与端到端支持,助力应对全球监管路径,确保从临床前阶段到上市批准的高效合规药物开发。

Phoenix WinNonlin Page

值得信赖的解决方案,适用于药代动力学(PK)、药效学(PD)及非房室分析(NCA)。

Operational Data Model (ODM) standard

How to Use CDISC’s ODM Standard for CRF Design Blog Post

Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA…

Certara’s Simcyp Consortium Celebrates 25th Anniversary Blog Post

The pre-competitive scientific research consortium of top pharmaceutical companies remains a critical force in advancing qualified PBPK modeling and simulation to further drug development and regulatory decisions RADNOR, PA –…