Latest News & Updates on Certara GlobalSubmit eCTD software

Certara has partnered with NVIDIA to integrate the NVIDIA BioNeMo Agent Toolkit into its AI-first biosimulation platform. This integration aims to enhance drug development workflows by embedding NVID...IA's life sciences AI stack into Certara's ecosystem, allowing AI agents to analyze biosimulation models and clinical datasets. This collaboration strengthens Certara's AI capabilities, potentially influencing its long-term investment narrative.
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Certara collaborates with Nvidia to integrate the Nvidia BioNeMo Agent Toolkit into its AI platform, enhancing drug development capabilities. This integration aims to assist in pharmaceutical R&D act...ivities like dose optimization and clinical data analysis, supporting Certara's goal of transforming drug development through computational biology.
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Certara has integrated its D360 scientific informatics platform with Secondary Intelligence software to enhance off-target pharmacology risk profiling for investigational drugs. This integration aims... to improve the prediction of drug safety risks by combining high-quality pharmacological data with advanced analytics, aiding scientists in selecting compounds with reduced off-target risks at earlier research stages.
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Certara has released D360 version 26.0, enhancing peptide drug discovery with improved sequence alignment and design capabilities. The new features include a design sandbox for creating virtual seque...nces and enhanced support for branched peptides. These updates aim to improve the efficiency of drug development by allowing scientists to analyze sequence-activity relationships and design peptides with better biological profiles.
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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 predicti...ons 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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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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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 ap...proach, 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 has launched the DIDB Concomitant Meds Navigator, a new software tool designed to identify contraindicated concomitant medications during drug studies. This tool, part of Certara's Drug Inter...action Database, helps research teams make informed decisions to protect study participants. It extends Certara's leadership in drug interaction science by providing comprehensive, up-to-date data on drug interactions, including investigational drugs and natural products.
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Certara has launched Pinnacle 21 Enterprise Plus, a solution designed to expedite regulatory submissions by reducing the time spent on drafting mapping specifications by 50%. This platform supports i...ndustry and proprietary standards, integrates seamlessly with tools like SAS and R, and aims to streamline the creation of submission-ready datasets, enhancing efficiency for clinical and statistical programmers.
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Certara has partnered with NVIDIA to integrate NVIDIA’s BioNeMo Agent Toolkit into Certara’s AI platform. This collaboration aims to enhance drug discovery and development workflows by using agen...tic AI to optimize dosing strategies, simulate clinical scenarios, and support regulatory submissions. The partnership seeks to combine AI with Certara’s biosimulation models to improve efficiency and maintain scientific oversight.
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Certara and NVIDIA have formed a strategic partnership to integrate NVIDIA's BioNeMo Agent Toolkit into Certara’s AI platform. This collaboration aims to automate drug discovery by creating 'AI sci...entists' capable of simulating human biology, enhancing drug development processes, and ensuring regulatory compliance. The partnership leverages NVIDIA's advanced AI frameworks to accelerate tasks like protein structure prediction and genomic analysis, positioning Certara at the forefront of AI-driven pharmaceutical innovation.
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Certara and Altasciences have formed a strategic partnership to enhance early-phase drug development. By integrating Certara's biosimulation technology with Altasciences' Acceleration Platform, the c...ollaboration aims to improve study designs, refine dosing strategies, and enable faster, informed decision-making. This model-first approach supports adaptive, data-driven drug development, aligning with FDA guidance and benefiting biotech sponsors and patients globally.
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Certara's Chemaxon has integrated its latest version of Marvin, a chemical sketcher, into Thieme's chemical databases, Science of Synthesis and Pharmaceutical Substances. This integration enhances th...e accuracy and user-friendliness of chemical structure drawing, streamlining tasks for chemists and improving synthesis planning. The integration required minimal development effort, demonstrating Marvin's ease of use and adaptability.
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Certara has partnered with Veeva AI to integrate Certaras CoAuthor generative AI solution with Veeva RIM, enhancing regulatory submissions for life sciences. This collaboration automates document cre...ation, streamlines data flows, and improves collaboration between data providers and regulatory writers, reducing preparation time by 30%. The integration allows seamless access to source files, expediting submission processes and improving accuracy.
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Veristat has agreed to acquire Certara's regulatory and medical writing business, enhancing its clinical development capabilities. The acquisition will add over 200 specialists to Veristat, strengthe...ning its support for regulatory submissions in complex therapeutic areas. The deal, backed by WindRose Health Investors, is expected to close in Q2 2026.
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Veristat has entered a definitive agreement to acquire Certara's Regulatory and Medical Writing business for up to $135 million. This acquisition will add over 200 professionals to Veristat's platfor...m, enhancing its regulatory strategy and medical writing capabilities. The deal, expected to close in Q2 2026, aims to streamline operations and support complex therapy submissions, reflecting consolidation trends in the CRO market.
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Certara has entered a definitive agreement to sell its Regulatory and Medical Writing business to Veristat for up to $135 million. The sale aligns with Certara's focus on expanding its Model-Informed... Drug Development (MIDD) and Clinical Intelligence solutions. The transaction is expected to close in Q2 2026, and Certara plans to update its 2026 guidance post-closure.
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Veristat plans to acquire Certara's Regulatory and Medical Writing business, enhancing its capabilities with over 200 experts. This acquisition, supported by WindRose Health Investors, aims to streng...then Veristat's position in regulatory affairs and medical writing. The transaction is expected to close in Q2 2026.
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Veristat plans to acquire Certara's Regulatory and Medical Writing business, enhancing its regulatory services with over 200 experts. This strategic move, supported by WindRose Health Investors, aims... to strengthen Veristat's capabilities in biostatistics, medical writing, and regulatory affairs, facilitating faster delivery of life-saving therapies. The acquisition is expected to close in Q2 2026.
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Certara has entered into a definitive agreement to sell its regulatory business, marking a significant divestiture for the company.

Certara reported its second quarter 2026 financial results, showing a 1% revenue growth to $93.3 million. Software revenue increased by 4%, while services revenue decreased by 3%. The company complet...ed a $100 million share repurchase and authorized an additional $50 million. Certara reaffirmed its revenue guidance for 2026, focusing on customer impact and execution speed.
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Certara reported Q2 2026 financial results with adjusted diluted earnings of $0.08 per share, missing estimates. Revenue rose 1.0% to $93.3M, driven by a 4.0% increase in the Software segment. The co...mpany continues to serve pharmaceutical and biotech clients with biosimulation tools.
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Certara reported Q2 2026 financial results with a revenue of $93.3 million, a 1% increase year-over-year. The company completed a $100 million share buyback and authorized an additional $50 million p...rogram. Leadership changes include Julien Perrier as Chief Commercial Officer and Eric Jahn as Chief Information Officer. The company also completed the divestiture of its Regulatory and Medical Writing business.
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Certara Inc's earnings report details quarterly and annual financial results, including revenue, profit, and financial ratios.

Certara will announce its second quarter 2026 financial results on August 4th, 2026, before the market opens. A conference call will follow at 8:30 AM ET to discuss the results. The webcast will be a...vailable on Certara's investor relations website.
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Certara will announce its Q2 2026 financial results on August 4, 2026, before market open, followed by a conference call. The company, a leader in model-informed drug development, serves over 2,600 c...lients globally. The announcement will provide insights into Certara's financial health and strategic initiatives.
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Certara reported a 1% increase in Q1 2026 revenue to $106.9 million, despite a 4% decline in services revenue. This led to a securities fraud investigation by Kirby McInerney LLP. The company's core ...biosimulation software remains crucial for drug development, supporting major pharma firms like Pfizer and Moderna.
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Certara reported its first quarter 2026 financial results, showing a 1% revenue growth to $106.9 million. Software revenue increased by 7% while services revenue decreased by 4%. The company posted a... net loss of $8.8 million, compared to a net income of $4.7 million in the previous year. Certara also completed the sale of its medical writing business to Veristat, LLC for $85 million.
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Certara announced its Q1 2026 financial results, reporting an adjusted EPS of $0.09, which missed analyst estimates of $0.11. The company achieved a total revenue of $106.9 million, reflecting a 1% g...rowth. Certara also reported a net loss of $8.8 million and an adjusted EBITDA of $31.7 million.
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Certara reported a Q1 2026 net loss of $8.8 million and completed the sale of its global medical and regulatory writing business to Veristat for up to $135 million. The divestiture impacts Certara's ...2026 revenue guidance, now set at $395–$405 million. Software revenue grew 7% to $49.7 million, while services revenue declined 4% to $57.2 million.
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Certara reported Q1 2026 revenue of $106.9 million, with software revenue up 7% and services revenue down 4%. The company sold its medical writing unit to Veristat for $85 million, aiming to focus on... drug development. Certara updated its 2026 revenue guidance to $395-$405 million.
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Certara is scheduled to release its quarterly earnings on Monday.

Certara will announce its first quarter 2026 financial results on May 11, 2026, before the market opens. A conference call to discuss these results will be held at 8:30 AM ET.

Certara will announce its earnings on May 11, with a webcast scheduled to start at 8:30 ET.

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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Certara reported a 9% revenue increase in 2025, driven by an 18% rise in biosimulation software revenue. Despite a net loss, adjusted EBITDA grew 10% to $134.5 million. Service bookings surged 17%, o...ffsetting a dip in software bookings. The company anticipates flat to 4% revenue growth in 2026, focusing on innovation and strategic execution under new CEO Jon Resnick.
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Certara reported its Q4 2025 financial results, with a revenue of $103.6 million, marking a 3% year-over-year growth. The company also provided its full-year 2026 guidance, anticipating revenue growt...h of 0-4% and an adjusted EBITDA margin of 30-32%. Certara's software revenue grew by 10%, driven by biosimulation software, while services revenue slightly decreased by 1%.
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Certara, Inc. will announce its fourth quarter and full year 2025 financial results on February 26, 2026. The company will host a conference call to discuss these results, with a live and archived we...bcast available on its website.
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Certara will announce its fourth quarter and full year 2025 financial results on February 26, 2026, before the market opens. A conference call to discuss the results will follow at 8:30 AM ET.

Certara, Inc. to Release Third Quarter 2025 Financial Results on ...

Certara will announce its second quarter 2025 financial results on August 6th, 2025, after market close. A conference call to discuss the results will follow at 5:00 PM ET.

Certara announced that Leif E. Pedersen has left his role as President and Chief Commercial Officer, effective August 1, 2026. He will remain as a Senior Advisor until December 31, 2026, to aid in th...e transition. This leadership change may impact Certara's go-to-market strategy and client relationships in the biopharmaceutical sector.
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Certara appointed Faiz Mohammed as interim CFO following the resignation of CFO John E. Gallagher III, effective July 14, 2026. The company is searching for a permanent successor while maintaining it...s 2026 financial guidance, indicating stability in its strategic and financial outlook.
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Certara appoints Faiz Mohammed as interim CFO following the resignation of Gallagher.

Certara announces the resignation of CFO John Gallagher, effective July 14, 2026, and appoints Faiz Mohammed as interim CFO. The company reaffirms its 2026 financial guidance, emphasizing stability a...nd continuity amid leadership changes. Certara is actively searching for a new CFO to maintain its strategic direction in the biopharmaceutical services sector.
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Certara's CFO John Gallagher will resign effective July 14, 2026. Faiz Mohammed, the Senior VP of Finance and Treasurer, will serve as interim CFO. Certara has hired an executive search firm to find ...a new CFO, indicating a focus on maintaining financial strategy and stability.
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Certara announced the resignation of CFO John Gallagher, effective July 14, 2026. Faiz Mohammed will serve as interim CFO. The company is actively searching for a permanent replacement.

Certara announced the resignation of CFO John Gallagher, effective July 14, 2026. Faiz Mohammed, Senior VP of Finance, will serve as Interim CFO during the search for a permanent replacement. Despite... the leadership change, Certara reaffirmed its 2026 financial guidance.
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Certara's CFO John Gallagher will resign on July 14, 2026. Faiz Mohammed, Senior VP of Finance, will serve as interim CFO. Certara has started a search for a new CFO and reaffirmed its 2026 financial... guidance.
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Certara's CFO John Gallagher resigns, effective July 14, 2026. Faiz Mohammed will serve as Interim CFO until a successor is appointed. Certara maintains its 2026 financial guidance.

Certara has appointed Dr. Britta Wagenhuber as Head of Quantitative Systems Pharmacology Consultancy. With over 14 years of experience in mechanistic model-informed drug development, she will enhance... Certara's AI-enabled QSP capabilities. Her role aims to accelerate drug development by improving decision-making processes and delivering innovative medicines to patients.
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Certara, Inc. has appointed Jon Resnick as CEO, effective January 1, 2026, succeeding William Feehery. Resnick, with over 20 years of experience at IQVIA, is expected to drive growth and innovation i...n drug development. Feehery will remain as an external advisor during the transition. The company reaffirms its 2025 financial outlook.
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Certara appointed Jon Resnick as CEO, effective January 1, 2026, succeeding William Feehery. Resnick, with over 20 years at IQVIA, brings extensive leadership experience in health sciences and busine...ss operations. Certara reaffirms its 2025 financial outlook and highlights its focus on advancing model-informed drug development.
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