Sealing Pharma Commercialization Deals: Creating Optimal Value for Investors On-Demand Webinar

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 strategy that will help drive acquisition potential, co-development prospects, and...

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...

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.