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ホーム / ニュース / Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Software for Evaluating Regulatory Submissions

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Software for Evaluating Regulatory Submissions

The PMDA enters 9th consecutive year of using Certara’s software

PRINCETON, N.J., 2022 年 10 月 19 日 — Certara, Inc., (Nasdaq: CERT) a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ Simulator, Phoenix™ biosimulation software, and Pinnacle 21™ Enterprise software. 

“The adoption of biosimulation and technology to advance novel drug development continues to grow in Japan,” said Certara’s CEO William Feehery, Ph.D. “We are proud of our ongoing partnership with the PMDA and industry leaders in Japan, as we work together to drive the use of innovative approaches and deliver critical therapies to patients sooner.”

The PMDA has been using Certara’s biosimulation software since 2014.  The PMDA also performs independent validation of clinical study data which CDISC compliance is required as part of sponsors’ regulatory submissions in their Pinnacle 21 Enterprise environment.  Pinnacle 21 Enterprise software supports the PMDA’s new validation rules, which were introduced at the end of 2021. 

Certara works with more than 140 biopharmaceutical companies and research institutions in Japan, including all of the top 20 Japanese biopharmaceutical companies by R&D spend.

For more information on Certara’s software, please visit https://www.certara.com/software/.


Certara(サターラ) について

サターラは、独自のバイオシミュレーションソフトウェア、テクノロジー、コンサルティングサービスを通して、従来の創薬・医薬品開発に変革をもたらすことをミッションとしています。2,000社の製薬企業、主要学術機関、世界各国の規制当局がサターラのソフトウェアやコンサルティングサービスを利用しております。(62か国)

投資家の皆様:

David Deuchler
Gilmartin Group
ir@certara.com

報道機関の皆様:

赤津 笑美
emi.akatsu@certara.com
ariane.lovell@finnpartners.com

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