Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software
September 19 2023 - 8:15AM
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
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