Skip to main content

Category: Brochure

Regulatory Solutions for Medical Device and Diagnostics

By

Certara’s MedTech specialists partner with medical device and diagnostic clients to reduce risk and accelerate approvals using advanced technology, an integrated approach, and industry-leading expertise. At any stage of the product lifecycle, our team of experts leverages extensive experience and knowledge of medical writing, regulatory pathways, commercialization, and lifecycle management to provide the unique support … Continued

Simcyp Discovery Simulator

By

Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers confidence in decision-making during the pre-Investigational New Drug (IND) application and translational development. Simcyp Discovery is based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, a regulatory-adopted, versatile tool in drug development that helps answer a myriad of “what if” questions … Continued

Infographic- Project Optimus

By

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus. With deep experience in model-informed oncology drug development, dosing and regulatory strategy and submission, we’ve helped advance hundreds of oncology programs. Our proven, integrated approach using quantitative methods can help you to navigate this regulatory change.

2 of 13