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 quality and consistency of pharmaceutical products. The quality portion of a submission (such as an IND, NDA, BLA, MAA, etc.) varies in complexity based on the synthesis route of the drug substance/active pharmaceutical ingredient (API) and the type of drug product (oral solid, oral liquid, topical, parenteral, etc.).

CMC documentation describes the methods and standards used in the manufacture and control of drug substances and drug products. This meticulous documentation is critical for regulatory submissions as it demonstrates that a pharmaceutical product meets safety, efficacy, and quality standards.

服务

CMC (Quality) Services, Regulatory Writing Services, Regulatory Submissions, Document Quality and Management Services

解决方案

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The challenge

Our client was seeking to develop a drug-device combination. They needed to re-write or update their IND Module 3 documents. This included 96 different CMC documents: 2 drug substances, 1 drug product, the placebo, and a complex dosing device.

The client had a clinical hold for almost 2 years, and they only had 1.5 months to resubmit these documents to the FDA.

Module 1 Administrative and prescribing information (not harmonized)

Module 2

数据质量
overall
概述

Non-clinical overall

Non-clinical summary

临床
overall

临床
概述

Module 3 Quality data

Module 4 Non-clinical study reports

Module 5 Clinical study reports

Figure 1. Investigational new drug applications (INDs) must adhere to the Electronic Common Technical Document (eCTD) format.

Figure 1. Investigational new drug applications (INDs) must adhere to the Electronic Common Technical Document (eCTD) format.

解决方案

A senior regulatory writer was assigned to rewrite, update, or review each of the 2 drug substances, the drug product, the placebo, and the device sections. The senior writer then assembled a team of support writers to help with the 96 documents.

Completing the project required daily meetings with the client. In addition to regulatory writing, Certara provided the submission leadership and expert support in presenting the data.

Certara’s Document Quality team worked round the clock utilizing our global QC team to ensure that quality control was done quickly and met the client’s tight timeline.

“We wanted to reach out and express my gratitude to Nellie and her team for the exemplary level of professionalism, expertise, and collaboration they have provided over the last several weeks. I have interacted with many companies/vendors in the past and this ranks as one of the best partnering experiences.”
Head of Manufacturing Science and Technology (MSAT)

优势

The client reviewed and approved all the Module 3 documents and resubmitted their IND to the FDA within the 1.5-month timeline. The clinical hold was lifted within a month of submission.

CMC 写作支持帮助客户解除临床搁置状态

The challenge

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CMC 写作支持帮助客户解除临床搁置状态

The challenge

解决方案

优势

联系我们

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临床试验数据的匿名化与删减处理的对比分析

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