GlobalSubmit™ REVIEW Page
Powerful but simple review of all your submissions across programs and stakeholders.
GlobalSubmit™ PUBLISH Page
Create health authority compliant eCTD submissions quickly and accurately.
Simcyp Simulator Impacts 80+ Novel Drugs Blog Post
250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels…
Can Biosimulation Provide the Key to Unlocking the Neurodegenerative Disease Development Challenge? Blog Post
By Professor Piet van der Graaf, Ph.D., and Hugo Geerts, Ph.D. Neurodegenerative diseases (NDs) affect millions of people worldwide. In the US alone, five million people suffer from Alzheimer disease;…
IQ WG Evaluation of PBPK Models for Organ-Impaired Populations Blog Post
• The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment (RI) and hepatic impairment (HI) populations was evaluated using clinical data from 29 compounds with…
Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors Blog Post
It is crucial for biotech developers to engage in early commercial market assessment to generate value for Regulators, Payers, and Clinicians. This approach should be integrated with a clinical development…
Privacy Notice for National Health Service (NHS) England Data Access Request Service (DARS) Page
Privacy Notice for National Health Service (NHS) England Data Access Request Service (DARS)
Controlled Terminology Best Practices Blog Post
Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve your submission process.
Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software Blog Post
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management software for their electronic common technical document (eCTD) submissions. The regulatory team at Prelude Therapeutics... Quantitative Systems Pharmacology for Drug Discovery and Development Blog Post
Certara’s Dr. Piet van der Graaf, Senior Vice President, Professor of Systems Pharmacology, Leiden University, and Editor-in-Chief of Clinical Pharmacology and Therapeutics presents the opening lecture for Pharmacology 2020.
