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

Rhea-AI Summary

Certara has announced the renewal of its software licenses with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the ninth consecutive year.

Certara's Simcyp™ Simulator, Phoenix™, and Pinnacle 21™ Enterprise software will continue to support PMDA in drug development and regulatory submissions.

The PMDA has utilized Certara’s software since 2014, significantly enhancing its data validation processes, including new compliance rules introduced in 2021.

Certara collaborates with over 140 biopharmaceutical companies in Japan, including the top 20 by R&D spending.

Positive

• Renewal of software licenses with PMDA enhances Certara's market position in Japan.
• Continuous usage of Certara’s software since 2014 indicates strong customer reliance.
• Increased adoption of biosimulation technology in Japan supports growth potential.
• Collaboration with top 20 biopharmaceutical companies in Japan boosts credibility.

Negative

• None.

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

PRINCETON, N.J., Oct. 19, 2022 (GLOBE NEWSWIRE) -- 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/.

About Certara
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com

Media Contact:
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com

 

FAQ

What is the significance of Certara's software renewal with PMDA?

Certara's software renewal signifies ongoing trust and reliance by PMDA on its biosimulation solutions, supporting drug development in Japan.

How long has PMDA been using Certara's software?

PMDA has been using Certara's software since 2014.

What software was renewed by PMDA from Certara?

PMDA renewed licenses for Certara’s Simcyp™ Simulator, Phoenix™, and Pinnacle 21™ Enterprise software.

What impact does the PMDA partnership have on Certara's business?

The PMDA partnership enhances Certara's reputation and credibility in Japan, leading to further growth opportunities.

How does Certara support biopharmaceutical companies in Japan?

Certara collaborates with over 140 biopharmaceutical companies in Japan, assisting in drug development and regulatory compliance.