Radnor, PA – 2024 年 11 月 25 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in model-informed drug development, today announced that a new version of its GlobalSubmit regulatory submissions software is generally available. The latest version supports the FDA’s new version 4.0 submission standard, improving the submission process while increasing harmonization across health authorities’ requirements.

Certara’s GlobalSubmit is used by regulatory affairs, medical writing teams, and scientists to efficiently publish, validate, and review Electronic Common Technical Document (eCTD) submissions of new drugs and biologics to health authorities. The latest version of Global Submit was developed with input from the FDA, current customers, and Certara’s large team of regulatory experts. GlobalSubmit has been used across the industry for over 15 years and has processed over 1.5 million regulatory submissions.

“Certara solutions support customers throughout the entire drug development lifecycle,” said William Feehery, CEO at Certara. “The latest version of GlobalSubmit, especially when combined with CoAuthor™, Certara’s generative AI-enabled regulatory writing platform, helps clients avoid risks and unnecessary delays during the submission process.”

The latest version of GlobalSubmit includes updated granularity, context groups, and re-used files. In addition to the GlobalSubmit software, Certara’s expert regulatory operations team provides the assurance needed to navigate the new standard seamlessly. The FDA is the second regulatory authority to begin accepting eCTD 4.0 submissions.

For more information on GlobalSubmit and Certara regulatory operations solutions, visit https://www.certara.com/globalsubmit-ectd-submission-software/

关于Certara

Certara 致力于通过生物模拟软件、技术和服务加速药物研发，改变传统的药物研发方式。其客户包括超 2,400 家生物制药公司、学术机构和来自 66 个国家的监管机构。Learn more at www.certara.com.

Certara 联系人:
Sheila Rocchio
{1}

媒体联系人：
Alyssa Horowitz
{1}