Rolling NDA and BLA Submissions: Accelerate Your Review Timeline Blog Post
We look at the growing regulatory trend of rolling NDA and BLA submissions to help accelerate FDA review, including benefits, challenges and risks.
Planning a Health Canada PRCI Compliant Submission Blog Post
How to set yourself up for a successful Health Canada PRCI submission
Certara (CERT) – Accelerating Medicines with Biosimulation Video
As seen on CNBC** Certara is the global leader in biosimulation, a powerful and proven technology. We transform traditional drug development by helping our customers create safe and effective medicines, faster. Certara (CERT) is proudly listed on Nasdaq.
Early HTA Engagement Page
Early HTA engagement ensures timely reimbursement and optimized market access strategies by aligning clinical evidence with HTA requirements.
Market Access Radar Page
Certara’s Market Access Radar is a carefully curated market access repository of the latest global market access news and reports. Learn more.
Regulatory Consulting and Regulatory Affairs Fact Sheet
Transparency and Disclosure Fact Sheet
Anonymization and Redaction Fact Sheet
Regulatory Writing Fact Sheet
Expert Writing. Faster Approvals. Read our Regulatory Writing Factsheet
The Promises and Pitfalls of Gene Therapy for Rare Diseases On-Demand Webinar
The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have raised questions about its promise. With only two gene therapies FDA-approved for rare diseases to date, the path to developing these medicines is still a...
