Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.
From Discovery through Development
Supporting Thirteen Recent Drug Approvals with Model Based Drug Development
Certara’s Pharsight Consulting Services is applying quantative models to decision making, helping accelerate FDA approvals.
Pharsight Consulting Services provides a full range of regulatory report writing services that reduce your risk of delays and increase your probability of success with regulatory submissions.
For more than 15 years, Pharsight scientists have helped clients understand, determine and quantitatively support dosing decisions. We have extended that expertise into Medical Writing services, so that the dosing rationale is clear and well understood by regulatory reviewers. We generate the following regulatory-compliant reports and common technical documents (CTD) that focus on the important clinical and pharmacological messages that impact dosing and labeling:
PK/PD, Efficacy, Safety and Tolerability Reporting (CTD Modules 4 and 5)
Overview and Summaries for NDA Submission (Module 2)