R Speaks NLME (RsNLME) Brochure
Download the brochure to learn more about RsNLME's features and benefits.
IQ WG Evaluation of PBPK Models for Organ-Impaired Populations On-Demand Webinar
• 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 106 organ impairment study arms were collected from 19 member...
PK Submit CDISC Technology Video
PK Submit automates the time consuming, error-prone and complex task of creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions. It allows you to automatically create a complete electronic regulatory submission-ready package within minutes during the...
Can Biosimulation Provide the Key to Unlocking the Neurodegenerative Disease Development Challenge? Press Coverage
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; 1 million from Parkinson disease; 400,000 from multiple sclerosis (MS);...
GlobalSubmit™ REVIEW Page
Certara's eCTD review software streamlines the regulatory submission review process to facilitate timely reviews of eCTD submissions.
GlobalSubmit™ PUBLISH Page
GlobalSubmit PUBLISH eCTD publishing software is designed to simplify the process of creating & submitting eCTDs to regulatory agencies.
DIA MASC Conference
Hear our experts speak about the Direct Use of AI in Clinical Regulatory Document Development: Real-World Use during DIA MASC 2024.
Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence Publication
The extent of cross-protection provided by currently licensed bivalent and quadrivalent HPV vaccines versus direct protection against HPV 31-, 33-, 45-, 52-, and 58-related disease is debated. A systematic literature review was conducted to establish the duration (...)
Purity is a Virtue: A Practical Guide to the Reporting of Impurities On-Demand Webinar
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and how to include them in their regulatory applications. This webinar is designed to increase the understanding of the regulatory guidances (e.g., ICH, FDA, and EMA)...
