Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines

PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to regulatory agencies worldwide. Submissions include those to initiate clinical trials, such as Investigational New Drug (IND) or Clinical Trial Application (CTA) and marketing applications, such as New Drug Applications (NDA), Marketing Authorization Applications (MAA), Supplemental New Drug Applications (sNDA), Biologics License Applications (BLA), EU Type II variations, and New Drug Submissions (NDS). Certara has supported clients’ global regulatory submissions across a wide range of therapeutic areas including cancer, rare diseases, central nervous system (CNS) diseases, and pediatrics.

“As the global regulatory drug development environment changes at an ever-increasing pace, Certara has combined regulatory writing expertise with technology platforms that streamline a complex process,” said Demetrius Carter, Sr. Vice President, Regulatory Sciences & Medical Affairs at Certara. “The impact for our clients has been the completion of high-quality submissions on time, resulting in faster approvals of life changing therapeutics for patients,” said Patrick Smith, President, Certara Drug Development Solutions.

Certara’s team of drug development and submission specialists have supported global submissions to the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Swiss Medic, Therapeutic Goods Administration (TGA), and Health Canada regulatory authorities. The expert team consists of writers, including chemistry, manufacturing, and controls (CMC), nonclinical, and clinical regulatory writers, submission leads, submission project managers, editors, and publishers, with many members holding advanced life science degrees. Our dedicated team of experts help clients deliver robust submissions in increasingly shorter timelines.

In addition to regulatory submission services, Certara offers a software portfolio that saves time and resources in submission development. The software portfolio includes:

• Pinnacle 21™ software used to facilitate all aspects of preparing clinical trial data for regulatory submissions.
• Synchrogenix™ Writer, an AI-powered regulatory and medical writing platform that streamlines document production.
• GlobalSubmit™ electronic common technical document (eCTD) submissions management software.

About Certara

Certara accelerates medicines using biosimulation software, technology, and services that transform traditional drug discovery and development. Its clients include more than 2,300 biopharmaceutical companies, academic institutions and regulatory agencies across 70 countries. Visit us at www.certara.com.

Certara Contact:

Sheila Rocchio

Sheila.rocchio@certara.com

Media Contact:

Ariane Lovell

Finn Partners

ariane.lovell@finnpartners.com