PRINCETON, N.J.—May 21, 2020 — New executives bring strategic and cross-disciplinary expertise to navigate changing regulatory environments
Tag: Drug Development & Regulatory Strategy
Watch this webinar to learn about tools & processes to help tailor COVID-19 therapies for special populations, including children and pregnant women
A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.
Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.
This webinar provided insights that could be used immediately in your development programs and could improve your readiness for deal and investment engagements.
Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
Changing the Game, Optimizing Success, Increasing Value: Committed to scientific and regulatory advancement, Certara has integrated its capabilities to create impactful healthcare solutions.
As your partner for drug development and regulatory strategy, Certara has expanded its services to offer GLP-compliant pre-clinical PK/TK NCA analysis and reporting.
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.