Regulatory Archives

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Protect Confidential Information in Investigational Drug Submissions

2025 年 3 月 20 日 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…

Becca Bucci2025 年 3 月 20 日

Publication

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

Danielle Pillsbury2025 年 3 月 20 日

Blog

临床试验数据的匿名化与删减处理的对比分析

2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…

Becca Bucci2025 年 1 月 17 日

Case Study

帮助申办方满足 EMA Policy 0070 要求

The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…

Danielle Pillsbury2025 年 1 月 7 日

Case Study

简化 1 年期和 2 年期 PSUR 的准备工作

We explore how we helped one client deliver a last-minute addition to a Periodic Safety…

Danielle Pillsbury2024 年 12 月 18 日

Case Study

及时对 EMA 安全性问题做出高质量回应

A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…

Danielle Pillsbury2024 年 12 月 12 日

Case Study

CMC 写作支持帮助客户解除临床搁置状态

In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…

Danielle Pillsbury2024 年 12 月 10 日

Blog

医学撰稿人协作创作指南

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…

Danielle Pillsbury2024 年 11 月 22 日

Blog

制定 EMA 政策0070 提交材料的常见问题解答

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…

Jim Gallagher2024 年 11 月 1 日

Blog

How To Respond to Health Authority Questions

Your biotech company has just submitted the marketing application for your first drug product. It’s…

Danielle Pillsbury2024 年 10 月 25 日

监管审批

Protect Confidential Information in Investigational Drug Submissions

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

临床试验数据的匿名化与删减处理的对比分析

帮助申办方满足 EMA Policy 0070 要求

简化 1 年期和 2 年期 PSUR 的准备工作

及时对 EMA 安全性问题做出高质量回应

CMC 写作支持帮助客户解除临床搁置状态

医学撰稿人协作创作指南

制定 EMA 政策0070 提交材料的常见问题解答

How To Respond to Health Authority Questions

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