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...
The Wizard of Oligos: There’s no place like having a successful drug development program! On-Demand Webinar
Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases— are experiencing tremendous growth in the pharmaceutical industry. But, performing the needed PK/PD and clinical pharmacology assessments to optimize the safety and efficacy...
eCTD Templates Page
Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
Maximizing Oligonucleotide Therapeutic Development: How They Work Blog Post
This blog explains how oligonucleotide therapeutics work and compares them with small molecule and biologic drugs.
