Are you prepared for the FDA’s phase out of animal tests for mAbs? On-Demand Webinar Are you prepared for the FDA’s phase out of animal tests for mAbs? Senior Vice President, Certara Drug Development Solutions Fran has over 25 years of experience with…CertaraApril 14, 2025
How Certara MIDD Experts Overcame Client Regulatory Challenges Case Study How Certara MIDD Experts Overcame Client Regulatory Challenges Certara’s Model-Informed Drug Development (MIDD) approach leverages an integrated, quantitative systems methodology to accelerate regulatory…CertaraApril 8, 2025
Standardizing Real World Data in Rare Disease: ATHN’s Journey Case Study Standardizing Real World Data in Rare Disease: ATHN’s Journey Learn how Certara helped ATHN standardize Real World Data for regulatory submissions, advancing rare disease…CertaraApril 8, 2025
Streamline Clinical Data Publication Under EMA Policy 0070 Blog Streamline Clinical Data Publication Under EMA Policy 0070 February 14, 2025 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…CertaraFebruary 14, 2025
Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling On-Demand Webinar Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate…CertaraFebruary 7, 2025
How to Validate Your Clinical Data Using FDA Validation Rules Blog How to Validate Your Clinical Data Using FDA Validation Rules January 30, 2025 For clinical data managers, understanding clinical data validation and applying FDA validation…CertaraJanuary 30, 2025