Regulatory Archives

Case Study

实现临床试验设计标准化的伟大梦想 — 一家生物制药公司的元数据自动化之旅

This case study explores how one biopharma gets deeper insights & more informed decision making…

Simona Colucci2024 年 5 月 13 日

Blog

对 FDA 新抗体-药物偶联物临床药理指南的思考

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…

Certara2024 年 5 月 10 日

Blog

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…

Certara2024 年 3 月 18 日

Blog

成功递交 eCTD 的最佳做法

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…

Certara2024 年 3 月 5 日

Conference

DIA MASC

Jim Gallagher2024 年 2 月 2 日

Blog

药物开发人员常见电子通用技术文件问题解答

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…

Certara2023 年 12 月 12 日

Blog

10 个关于 eCTD 4.0 的须知事项：迎接未来的监管提交

In this blog post, we explore the top 10 things you need to know about…

Certara2023 年 10 月 17 日

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

Certara2023 年 9 月 21 日

Case Study

利用药代动力学建模和科学传播专长推进肉样瘤病药物项目

Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…

Danielle Pillsbury2023 年 6 月 1 日

Case Study

Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial

Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…

Danielle Pillsbury2023 年 4 月 17 日

监管审批

实现临床试验设计标准化的伟大梦想 — 一家生物制药公司的元数据自动化之旅

对 FDA 新抗体-药物偶联物临床药理指南的思考

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

成功递交 eCTD 的最佳做法

DIA MASC

药物开发人员常见电子通用技术文件问题解答

10 个关于 eCTD 4.0 的须知事项：迎接未来的监管提交

Maximizing Reusability for Drug Submissions to Different Health Authorities

利用药代动力学建模和科学传播专长推进肉样瘤病药物项目

Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial

订阅时事通讯

快捷链接

解决方案

联系我们