Product Business Settings

Certara GlobalSubmit eCTD software is popular in Pharmaceuticals industry and is widely used by Enterprise.

Certara GlobalSubmit eCTD software Product Overview

Globalsubmit provides eCTD submission software to mitigate rejection risks in a complex regulatory environment. Differences in regulatory requirements complicate the submission process.

How satisfied the customers are with Certara GlobalSubmit eCTD software use-cases

Reviews

"...GlobalSubmits approach to document management is a familiar one intuitive interface, easy implementation that appeals to the novice user, built-in templates and workflows, and integration with eCTD publishing systems...." Peer review

Certara GlobalSubmit eCTD software Customer Insights, Testimonials and Case Studies

lightning

Peers used Certara GlobalSubmit eCTD software for sending & publishing communications and workflow management

Certara GlobalSubmit eCTD software Features

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FEATURE RATINGS AND REVIEWS
Custom Reports

4.34/5 ★

Read Reviews (48)
Analytics

3.26/5 ★

Read Reviews (1)
CAPABILITIES RATINGS AND REVIEWS
Custom Reports

4.34/5 ★

Read Reviews (48)
Analytics

3.26/5 ★

Read Reviews (1)

Software Failure Risk Guidance

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for Certara GlobalSubmit eCTD software

Overall Risk Meter

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Top Failure Risks for Certara GlobalSubmit eCTD software

Certara, USA. News

Financial
 

Certara Conference: 2025 revenue hits guidance, EBITDA margin tops ...

Certara reported 2025 organic software revenue growth of 7% and an adjusted EBITDA margin of 32%, despite a decline in Q4 software bookings. The company launched three new software offerings: Certara IQ for QSP, Phoenix Cloud, and a Pinnacle enhancement. These launches are expected to drive growth in 2026. Certara also highlighted its AI strategy and potential changes in its regulatory services segment.

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Product
 

Certara Simcyp Simulator Results Replace Ten Human Trials for Ch

Certara's Simcyp Simulator has been used to replace ten human trials for the Chronic Myeloid Leukemia therapy, asciminib. The U.S. FDA accepted physiologically-based pharmacokinetic modeling predictions from the simulator, aiding the new drug application. This approach enhances drug development efficiency by simulating drug interactions and dosing regimens, supporting regulatory approval.

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Product
 

Certara Inc Announces Simcyp Simulator Results Replace Ten Human Trials ...

Certara Inc. announced that its Simcyp Simulator's physiologically-based pharmacokinetic (PBPK) modeling results have been accepted by the U.S. FDA to replace ten human trials for the drug asciminib, used in treating Chronic Myeloid Leukemia. This innovative approach supports the new drug application by predicting drug interactions and pharmacokinetics, enhancing regulatory decision-making and potentially expediting drug approval processes.

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Product
 

Certara Simcyp Simulator Results Replace Ten Human Trials for Chronic Myeloid Leukemia (CML) Therapy asciminib

Certara's Simcyp Simulator has successfully replaced ten human trials for the Chronic Myeloid Leukemia therapy, asciminib, using physiologically-based pharmacokinetic modeling. This model-informed approach, accepted by the U.S. FDA, supports the new drug application by predicting drug interactions and optimal dosing. The collaboration with Novartis highlights the simulator's role in regulatory decision-making and drug development.

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Certara, USA. Profile

Company Name

Certara, USA.

Company Website

https://www.certara.com/

HQ Location

123 South Broad Street, Suite 1850, Philadelphia, PA 19109, US

Employees

11-50

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Financials

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