eCTD 4.0: When & Where it will be Implemented Next Blog Post
講演者Maryanne Loscalzo Associate Director, Regulatory Operations Over 20 years of experience in eCTD submissions and FDA interactions. Rachel Bombara Sr. Regulatory Services Manager Rachel Bombara has more than 13...
Write Quicker PBPK Reports with the Simcyp Report Assistant Blog Post
Harry Moore 2025年4月11日 Writing a report for PBPK models can be an onerous process, especially when the report requires the compilation of data from different sources. Simcyp COV...
How Certara MIDD Experts Overcame Client Regulatory Challenges Blog Post
サターラのモデルを活かした医薬品開発 (MIDD) コンサルティングサービスは、定量的アプローチを全面的に取り入れ、時間とコストを最小限に抑えながら、規制当局からの承認申請と商業的成功をサポートしています。臨床薬理学、薬物動態学、規制戦略、マーケットアクセスに関する...
Standardizing Real World Data in Rare Disease: ATHN’s Journey Blog Post
Learn how Certara helped ATHN standardize Real World Data for regulatory submissions, advancing rare disease research with compliant, actionable insights.
A Quick Guide to SDTM Dataset Creation APAC PA Page
GUIDEA Quick Guide to SDTM Dataset Creation Our quick guide can help you create your SDTM datasets faster and easier. What you’ll learn The basics of SDTM dataset creation, including...
Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities Blog Post
RADNOR, PA — April 1st, 2025 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in model-informed drug development, has released a new version of the Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling.
Exploring Common CDISC ADaM Conformance Findings Blog Post
Trevor Mankus Product Manager 2025年3月27日 Intro to CDISC ADaM Conformance ADaM data are required by the FDA and PMDA and accepted by China’s NMPA. Agencies often begin reviews...
