Radnor, PA – 2024年11月25日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) は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/
Certara（サターラ）について
サターラは、モデリング＆シミュレーション・ソフトウェアと技術を用いて、従来の創薬・開発を変革し、医薬品をよりスピーディーに患者さんに届けることをミッションとしています。製薬、教育機関、規制当局のお客様 2,400人以上、66ヵ国にてサターラの技術やサービスが活用されています。詳細は弊社ホームページをご覧ください。
お問合せ先
Sheila Rocchio
sheila.rocchio@certara.com
報道機関の皆様：
赤津笑美 (emi.akatsu@certara.com)
certara@pancomm.com
