Certification Resources & FAQ Page

Preparing for the Certification Courses Frequently Asked Questions 1. Do I need to install or have access to the software version that I am being certified on?It is recommended to practice your skills using Phoenix on the version for which...

Safety and Pharmacovigilance Page

Explore Certara's Pharmacovigilance (PV) writing services for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.

Academic Centers of Excellence Page

As regulators and sponsors recognize the growing importance of model-informed drug development (MIDD), Certara is committed to educating the next generation of experts in this field, on a global basis. We are achieving that goal by partnering with eminent scientists...

Using PBPK Models to Assess Fetal Drug Exposure Blog Post

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than...

Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption Blog Post

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both...

Using a Pharmacology to Payer Framework to Support Product Development Blog Post

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development...

Achieving Compliance with the FDA’s eCTD Mandate Blog Post

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF...

Overcoming Pitfalls and Challenges with Software Validation Blog Post

As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical,...