Category: 資料
Drug Discovery & Development with Deep Learning Advanced Analytics
Solutions to Meet All Needs: From Small Biotech to Large Global Pharma
Vyasa Layarの概要
Regulatory Solutions for Medical Device and Diagnostics
Certara’s MedTech specialists partner with medical device and diagnostic clients to reduce risk and accelerate approvals using advanced technology, an integrated approach, and industry-leading expertise. At any stage of the product lifecycle, our team of experts leverages extensive experience and knowledge of medical writing, regulatory pathways, commercialization, and lifecycle management to provide the unique support … Continued
BaseCase Portal
Medical Devices & Diagnostics
Simcyp Discovery Simulator
(シムシップ・ディスカバリー・シミュレーター)
Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers confidence in decision-making during the pre-Investigational New Drug (IND) application and translational development. Simcyp Discovery is based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, a regulatory-adopted, versatile tool in drug development that helps answer a myriad of “what if” questions … Continued
Lightspeed で書く優れた計画立案により、今日の環境下で提出書類を最適化
インフォグラフィックから学ぶ:米国FDAプロジェクト・オプティマス
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus. With deep experience in model-informed oncology drug development, dosing and regulatory strategy and submission, we’ve helped advance hundreds of oncology programs. 定量的手法による当社のアプローチや実績で、お客様がプロジェクト・オプティマスによる規制的な変更を乗り切れるよう支援いたします。