Regulatory Archives

On-Demand Webinar

纯洁是一种美德：杂质报告的实用指南

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and…

Certara2021 年 3 月 23 日

Case Study

利用 Certara GlobalSubmit eCTD 软件，Prelude Therapeutics 将其质量控制 (QC) 流程从数小时缩短到了数分钟

In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management…

Certara2021 年 3 月 2 日

Press Release

Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe

Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— 2021 年 3 月 2 日–…

Certara2021 年 3 月 2 日

Blog

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy…

James Zoshak2021 年 2 月 22 日

Blog

Why Consistency in Patient Safety Narratives is Crucial

“You would not be able to tell 40 different writers were authoring these. It looked…

Gabriella Mangino2021 年 2 月 9 日

On-Demand Webinar

RAPS 赞助的网络研讨会：效率与技术为产品说明撰写的新时代铺平道路

医学叙述是医学写作的核心组成部分。Sponsors sometimes need to prepare large…

Certara2021 年 2 月 8 日

Blog

Regulatory submissions and transactions with Health Canada

By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions…

Rob Labriola2020 年 11 月 19 日

On-Demand Webinar

按部就班，保证睡眠：市场营销应用最佳实践

Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone…

Certara2020 年 10 月 7 日

Fact Sheet

监管运营

Jieun Choe2020 年 8 月 13 日

Fact Sheet

科学和医学通讯

Jieun Choe2020 年 8 月 13 日

监管审批

纯洁是一种美德：杂质报告的实用指南

利用 Certara GlobalSubmit eCTD 软件，Prelude Therapeutics 将其质量控制 (QC) 流程从数小时缩短到了数分钟

Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

Why Consistency in Patient Safety Narratives is Crucial

RAPS 赞助的网络研讨会：效率与技术为产品说明撰写的新时代铺平道路

Regulatory submissions and transactions with Health Canada

按部就班，保证睡眠：市场营销应用最佳实践

监管运营

科学和医学通讯

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