Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Post
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)),…
Top Lessons Learned from 300 Regulatory Submissions Blog Post
Who would have thought when we completed work on the first submission for which we ever authored 3 or more documents and provided strategic support (our criteria for saying that…
Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software Blog Post
Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software PRINCETON, N.J.— September 19, 2023 – Certara, Inc., a global leader in biosimulation software, today announced the release of Phoenix…
Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software Blog Post
Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines. PRINCETON, NJ – September 19th, 2023 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it…
What is ICER & How Does it Impact the Pharmaceutical Industry? Blog Post
The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization. ICER’s mission is to conduct evidence-based reviews of healthcare interventions that help guide patients, doctors,…
Clinical Pharmacology Regulatory Strategy Page
Partner with Certara for Clinical Pharmacology Regulatory Strategy to optimize drug development pathways and navigate complex regulatory landscapes.
Methods to Increase Signal Finding in Rare Disease Drug Development Blog Post
The regulatory landscape for drugs to treat rare diseases is being disrupted. Gleaning from several recent health authority advisory committee deliberations have provided a glimpse into the science and complexity…
Simcyp Publications and Independent Applications Page
Simcyp™ Publications and Independent Applications Driving drug development innovation with Simcyp Simcyp publication statistics We are proud to share our publications by the Simcyp R&D Team (1997 – Present) and...
How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted Blog Post
Discover how a biotech startup enhanced flexibility and efficiency by adopting Phoenix Hosted, streamlining workflows and unlocking greater productivity.
