Strategic Consulting and Advisory Services
Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Software Portfolio: 'End-to-end' Modeling
Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
Certara's Programmatic Consulting Approach Delivers Unquestionable Value to Sponsor Companies
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
Leading Edge Science: Resource Library
Check out the latest brochures, case studies, white papers, webinars, and more! Search by keywords and/or filter results.
Press Releases
Certara Staff to Demonstrate Drug Development Solutions at Scientific Webinar Series
February 06, 2015
Topics to be presented will include PBPK modeling and simulation, population modeling of e-cigarettes, and artificial intelligence technology for clinical trial transparency.
Certara Promotes Prof. Amin Rostami to Senior Vice President of R&D and Chief Scientific Officer
January 29, 2015
Rostami is recognized for his scientific leadership, original thinking, and commitment to knowledge sharing with his colleagues and students
Certara Updates Phoenix WinNonlin Validation Suite to Streamline Computer System Validation
January 27, 2015
Phoenix® WinNonlin® Validation Suite™ 4.0 can help ensure compliance, reduce total cost of ownership and improve work efficiency
Certara Appoints Gavin Nichols as President of Technology and Head of its Software Business Unit
January 20, 2015
Nichols brings more than 25 years of technology leadership in clinical informatics and advanced analytics to the company
Synchrogenix, Certara’s Regulatory and Medical Writing Consultancy, Acquires ClinGenuity
January 06, 2015
Deal provides Synchrogenix with proprietary technology, expert staff, and new capabilities to become the dominant player in life science regulatory and medical writing
Certara VP and Lead Scientist Evaluates Pivotal Study at Cardiac Safety Research Consortium Meeting
December 23, 2014
Study results support replacing the expensive and time-consuming TQT study with QT assessment in early clinical development
Certara Launches Muse Invent in Japan; It Allows Researchers to Design Synthetically Feasible Drugs
December 09, 2014
Muse Invent enables researchers not only to design dream molecules, but it also shows how to produce them in the lab
PK/PD Data Analysis Experts to Lead Advanced Model-Based Drug Development Workshop
November 21, 2014
Drs. Daniel Weiner and Johan Gabrielsson will show how to build PK/PD models to optimize drug doses and regimens used in clinical trials
Certara Updates its Simcyp Simulator Used to Predict Drug Behavior in Virtual Patient Populations
November 19, 2014
Simcyp Simulator advances drug development and regulatory approval for majority of top 40 pharma companies
Certara Updates its Industry-leading PK/PD Phoenix Platform and Introduces Phoenix Quantum
November 03, 2014
Release includes updates to Phoenix WinNonlin, the gold standard for pharmacokinetic and pharmacodynamics (PK/PD) modeling used in preclinical and clinical drug development
Certara Consultants to Present PK/PD Modeling Advances at the AAPS Annual Meeting and Exposition
October 31, 2014
Certara will participate in 10 seminars and forums, launch the new version of its Phoenix PK/PD software platform, and support the National Organization for Rare Disorders during the show.
Certara Receives FDA Grant to Enhance Simcyp Simulator’s Mechanistic Dermal Absorption Model
October 23, 2014
Enhanced solution will be able to model additional populations, and diseases, and also consider new mechanisms that impact dermal absorption.
D360 User Group Meeting Hailed as “Highly Informative and Incredibly Valuable”
October 17, 2014
User Group Meeting "Highly Informative and Incredibly Valuable," Says D360 Clients
Certara Consultants to Discuss PK/PD Modeling Advances and ISoP Standards at ACoP5
October 08, 2014
Certara consultants will present a total of five seminars and five posters at ACoP5 being held from Oct. 12-15 in Las Vegas, Nev.
Certara’s New Muse Invent Allows Researchers to Design Synthetically Feasible Drug Candidates
August 11, 2014
A breakthrough development, Muse® Invent™ enables researchers not only to design dream molecules, but it also shows how to produce them in the lab.
Top 5 Pharma Company Chooses Certara’s D360 as its Global Drug Discovery Platform
June 06, 2014
D360™ will provide enhanced data access and visualization to enable rapid decision making and reduce attrition rates
Certara Appoints New CEO Dr. Edmundo Muniz
June 05, 2014
A physician, drug developer, and scientist, Dr. Muniz brings both big pharma and small biotech experience to his new role
Pre-clinical Safety Store Captures and Validates File-based Study Data in a CDISC-SEND Database
April 29, 2014
Certara introduces new product that will serve as a companion product and preclinical data source for D360, supporting ongoing study monitoring and cross-study analyses.
Certara Acquires Specialty Contract Research Organization Synchrogenix
April 15, 2014
Purchase adds global regulatory writing and submission services to Certara’s drug development consulting expertise.
Biothera Presents Pharmacokinetic Data for its Cancer Immunotherapy Imprime PGG
March 21, 2014
Certara partnered with Biothera, contributing to the findings through population PK modeling to support dosing rationale, assessment of potential drug-drug interactions.