Certara

What Certara does

Certara, Inc. is a Princeton, New Jersey-based biosimulation and regulatory science company that provides model-informed drug development (MIDD) software and services to pharmaceutical, biotechnology, and contract research organizations across more than 70 countries. Its platform combines proprietary PBPK modeling (Simcyp), PK/PD analysis (Phoenix), clinical data standardization and CDISC validation (Pinnacle 21), scientific informatics (D360), cheminformatics (Chemaxon, acquired October 2024), and value communication (BaseCase) with AI-enabled modules such as Certara IQ (QSP), CoAuthor (GenAI regulatory writing), Certara.AI, and the Non-Animal Navigator. Certara's software is licensed by 21 regulatory agencies worldwide and has been used in lieu of clinical studies for 120+ novel drug approvals and 325 label claims.

The company generates revenue through two streams: software (SaaS and perpetual licenses across the Phoenix, Pinnacle 21, Simcyp, Certara IQ, D360, GlobalSubmit, CoAuthor, and Chemaxon platforms; $49.7M in Q1 2026, +7% YoY) and services (modeling and simulation consulting, biometrics, regulatory strategy, real-world evidence, and therapeutic specialty services; $57.2M in Q1 2026, -4% YoY). Pricing is quote-based, with enterprise software sold via subscription or perpetual licenses and services priced per project or time-and-materials. Customers are concentrated in three primary verticals: large pharma (e.g., Merck, Novartis, Biogen, Biohaven), biotech (e.g., Dizal, Arvinas, Scorpion Therapeutics), and CROs, served through a direct enterprise field-sales motion with inside-sales support for mid-market accounts.

Certara completed its IPO in September 2021 (NASDAQ: CERT) and operates with 1,550+ employees across more than 30 countries, including 440+ PhD-level scientists. Arsenal Capital Partners holds approximately 22% of shares following a $449M secondary purchase in November 2022. In May 2026, Certara divested its Regulatory and Medical Writing Business to Veristat for up to $135M, sharpening the portfolio around higher-margin software and biosimulation services. Leadership transitioned in January 2026 with Jon Resnick (ex-IQVIA) becoming CEO, while CFO John Gallagher announced his departure effective July 2026.

Name

Certara

Legal name

Certara, Inc.

Website

https://certara.com

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Certara provides biosimulation software and model-informed drug development services to 2,600+ pharmaceutical, biotech, and CRO clients across 70 countries. Its platform spans PBPK modeling (Simcyp), PK/PD analysis (Phoenix), CDISC validation (Pinnacle 21), and AI-enabled regulatory and discovery modules.

Ownership category

akta.pro rank

Product category

Biosimulation and Drug Development Software

NAICS

Software Publishers (51321), Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Prepackaged Software (7372), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

Keywords

• Biosimulation software
• Model-informed drug development
• Pharmacokinetic modeling
• Regulatory submission software
• Clinical data standardization

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Software Revenue: SaaS and perpetual software licenses including Phoenix, Pinnacle 21, Simcyp, Certara IQ, D360, GlobalSubmit, CoAuthor, Chemaxon, and BaseCase platforms. Software revenue grew 7% year-over-year to $49.7 million in Q1 2026.
2. Services Revenue: Professional services including modeling and simulation consulting, biometrics and data science, drug development support, regulatory strategy, real-world evidence, and therapeutic specialty services. Services revenue was $57.2 million in Q1 2026, representing a 4% decline year-over-year.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Certara develops and licenses proprietary biosimulation software and provides drug development services that enable pharmaceutical, biotech, and CRO customers to predict drug behavior, optimize trial design, and accelerate regulatory submissions. Its platform portfolio includes Phoenix (PK/PD), Simcyp (PBPK), Pinnacle 21 (CDISC data standardization), D360 (discovery informatics), Certara IQ (QSP), CoAuthor (GenAI regulatory writing), and Chemaxon (cheminformatics), complemented by professional consulting services in modeling, biometrics, regulatory strategy, and real-world evidence.

Product overview

Certara offers a comprehensive platform-plus-modules architecture for model-informed drug development (MIDD), combining biosimulation software, clinical data standardization tools, and AI-powered analytics across the drug development lifecycle. The core product portfolio centers on Phoenix (PK/PD analysis platform), Pinnacle 21 (clinical data standardization), Simcyp (PBPK modeling), and D360 (scientific informatics), complemented by AI-enabled modules including Certara IQ (QSP modeling), Certara.AI, and CoAuthor (regulatory writing). Additional specialized tools address specific workflows: GlobalSubmit for eCTD submissions, BaseCase for value communication, SEND Explorer for nonclinical data, and Chemaxon (acquired 2024) for cheminformatics. The platform serves discovery through market access phases, with regulatory agencies worldwide licensing Certara software products.

Differentiator

Problem solved

Functional benefit

Brands

• Phoenix: PK/PD analysis and modeling platform for pharmacokinetic and pharmacodynamic data analysis, non-compartmental analysis, population PK, and IVIVC
• Pinnacle 21
• Simcyp
• D360
• Certara.AI
• CoAuthor
• BaseCase
• GlobalSubmit
• Certara IQ
• SEND Explorer
• Chemaxon
• Non-Animal Navigator

Products and services

• Phoenix PK/PD Platform Industry-standard PK/PD analysis and modeling platform used by 11,000+ users and 2,600+ companies for non-compartmental analysis (NCA), population PK (popPK), IVIVC, and toxicokinetic modeling. Includes WinNonlin, NLME, IVIVC Toolkit, and Phoenix Cloud modules. Trusted by 11 global regulatory agencies including the US FDA.
• Pinnacle 21 Enterprise Clinical data standardization and validation software suite with 19,000+ users and 17 years of CDISC leadership, providing metadata management, define.xml generation, issue tracking, and external vendor data exchange for regulatory submissions.
• Simcyp PBPK Simulator Industry-leading physiologically-based pharmacokinetic modeling platform for predicting drug behavior in diverse populations. Licensed by 21 regulatory agencies worldwide and used in 120+ novel drug approvals in lieu of clinical studies.
• D360 Scientific Informatics Platform Premier informatics platform for managing and analyzing complex drug discovery data, enabling scientists to access, analyze, and visualize molecule and bioactivity information. Used by 6,000+ scientists.
• Certara IQ AI-enabled Quantitative Systems Pharmacology (QSP) modeling software that scales QSP modeling with validated models, workflows, and regulatory-ready insights for predicting drug performance.
• Chemaxon Complete cheminformatics workbench for molecule design, property calculation, search, and data management, used by 750,000+ users. Acquired by Certara in October 2024 for $90 million.
• GlobalSubmit eCTD submission software for publishing, validating, and reviewing regulatory submissions to eliminate risk and expedite regulatory acceptances.
• CoAuthor GenAI-powered regulatory writing solution that accelerates document creation with AI-generated content, templates, and structured content for compliance.
• BaseCase Value Communication Platform Interactive value communication software empowering market access teams to showcase product value with data-driven stories.
• Non-Animal Navigator Expert strategy and AI-enabled biosimulation solution that helps drug developers reduce, refine, or replace animal studies with NAM (New Approach Methodologies) strategies and regulatory alignment.
• Certara.AI AI platform designed for life sciences to solve data silo problems while improving analytics capabilities and boosting productivity across drug development.
• Phoenix Cloud Cloud-based PK/PD platform offering streamlined data compliance and management with TFL Studio module for generating tables, figures, and listings for regulatory submissions.
• SEND Explorer Validated web-based application providing advanced viewing, data summarization, and visualization capabilities for nonclinical data in SEND format.
• Modeling and Simulation Services Professional consulting services using predictive biosimulation and modeling to inform dosing, safety, and efficacy decisions across drug development. Delivered by Certara's 700+ drug development scientists.
• Regulatory Strategy Services Regulatory affairs consulting to optimize drug development strategy and achieve regulatory milestones across global jurisdictions.
• Bio Venture Catalyst Service for emerging biotechs to de-risk investment and accelerate development through funding support and strategic guidance.
• Market Access Radar Tool delivering up-to-date pricing and reimbursement data from global sources to navigate market access challenges for pharmaceutical products.
• Phoenix WinNonlin Gold standard for non-compartmental analysis, PK/PD modeling, and toxicokinetic modeling from AUC calculations to tables, figures, and listings.

Quantifiable outcome

• Reduces drug development timeline by 10+ months per program
• +5 more outcomes

Named customers9 records

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability6 records

Feature10 records

Partnerships

Five partnerships are on record, tiered strategic, minor, major and regional.

• AltasciencesstrategicStrategic or Co-development Partner · 7 May 2026Strategic partnership to integrate Certara's biosimulation technology and model-informed drug development services with Altasciences' drug development Acceleration Platform. Collaboration aims to help biotech sponsors establish proof of mechanism earlier, optimize study designs, and make more informed go/no-go decisions, addressing the industry challenge where fewer than half of preclinical candidates reach first-in-human trials. Partnership aligns with FDA's advancing guidance supporting adaptive, data-driven drug development approaches.
• Cirius TherapeuticsminorStrategic or Co-development Partner · 28 April 2026Certara engaged to provide specialized maternal-fetal and lactation modeling expertise using the Simcyp Simulator for Cirius Therapeutics' gestational diabetes initiative, with potential future clinical trials planned for low- and middle-income country settings.
• VeristatmajorStrategic or Co-development Partner · 22 April 2026Acquisition of Certara's Regulatory and Medical Writing Business by Veristat, adding more than 200 regulatory and medical writing experts to Veristat's platform. Transaction completed May 8, 2026 for $85 million cash (plus $15 million escrow and up to $35 million earn-out). Divested business generated $50 million in revenue and $17 million in adjusted EBITDA in 2025.
• CelltrionregionalStrategic or Co-development Partner · 22 May 2025First Korean partnership announced to boost global drug development. Certara's first partnership in Korea targeting regional pharmaceutical market expansion.
• ChemaxonmajorTechnology or Integration · 1 October 2024Acquisition of Chemaxon, a Hungary-based cheminformatics software company for $90 million in cash. Deal completed October 2024, strengthening Certara's drug discovery platform by integrating Chemaxon's cheminformatics and bioinformatics software. Projected to contribute over $20 million in software revenue for Chemaxon in 2024.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• IQVIA: Largest global CRO and life sciences analytics provider with deep biotech and pharma relationships. Comparable to Certara because both sell biosimulation-adjacent consulting, real-world evidence, and technology services to overlapping pharma/biotech buyers; new Certara CEO Jon Resnick joined from IQVIA.
• ICON plc: Global CRO with significant biometrics, regulatory, and biosimulation-adjacent services following the PRA Health Sciences merger. Competes with Certara's services business for pharma outsourcing budgets and increasingly partners with biosimulation specialists.
• Parexel International: Global mid-tier CRO with strong biometrics, regulatory consulting, and clinical pharmacology services. Overlaps with Certara's services offerings across regulatory strategy, biometrics, and PK/PD consulting for biopharma sponsors.
• Charles River Laboratories: Preclinical and clinical CRO with a sizable scientific software and services portfolio. Overlaps with Certara in early-stage drug development services, safety assessment analytics, and biostatistics for biotech and pharma customers.
• Labcorp: Diagnostics and early development CRO (including Covance and early development assets) with biosimulation-adjacent translational services. Competes with Certara for clinical pharmacology and translational medicine budgets and serves overlapping pharma/biotech customers.
• OpenText: Enterprise information management vendor with a regulatory information management footprint (formerly CSC/Surety). Comparable to Certara's GlobalSubmit and broader RIM software stack as an alternative for regulatory submission publishing and compliance.

Direct peers

• Veeva Systems: Cloud software platform purpose-built for life sciences, spanning clinical, regulatory, and quality workflows. Directly comparable to Certara on regulatory submission software and clinical data management, both competing for the same pharma IT budget against solutions like GlobalSubmit and Pinnacle 21.
• Schrödinger: Computational chemistry and physics-based drug discovery platform with both SaaS and co-development revenue. Comparable to Certara's biosimulation franchise — particularly Certara IQ and D360 — because both sell predictive modeling platforms to discovery and translational scientists in pharma and biotech.
• Simulations Plus: Specialist in PBPK/QSP modeling software (GastroPlus, MonolixSuite, Immunetrics) serving the same model-informed drug development niche. Most direct head-to-head competitor against Simcyp, Phoenix, and Certara IQ in biosimulation software.
• Medidata Solutions (Dassault Systèmes): Clinical trial technology platform including EDC, CTMS, and eCOA within the Dassault Systèmes 3DEXPERIENCE life sciences portfolio. Directly comparable to Pinnacle 21, Formedix, and Trial Simulator for CDISC-compliant clinical data management and submission workflows.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/certara
• YouTubeyoutube.com/user/CertaraLP
• Facebookfacebook.com/certaralp
• LinkedInlinkedin.com/company/certara

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries4 records

Funding overview

Funding rounds6 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A13 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Certara