Therapeutic Areas of Expertise: Modeling, Simulation, Strategic Pharmacometric Services, and Regulatory Writing

Certara's global consulting team has unparalleled experience across all development phases and in all major therapeutic areas, spanning 80+ disease indications and 130 drugs. We work on both small molecules and biologics, infectious disease, gender-related and global health challenges.  Our expertise in rare, orphan indication and difficult to treat conditions have supported the approval of more than 40 new drugs. 

Our modeling work has enabled clients to leverage from one indication to another, based on small clinical trials and evidence from a previous indication.  We have collaborated with clients to support key trial design and program-level development decisions at every point along the regulatory timeline.  

Our team has especially broad and deep expertise in the following therapeutic domains.

Leveraging our experience working on thousands of key modeling and simulation projects on behalf of hundreds of biopharm companies, Certara Strategic Consulting brings its track record of success and a broad range of expertise to each assignment.  Strengthening our service is Synchrogenix, our scientific and regulatory writing consultancy, which provides the highest quality regulatory writing across pre-clinical, clinical, CMC and drug safety filings.