by Heather Gillman | Jul 28, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Jim Sergi INTRODUCTION The pathway for transitioning to a successful US FDA IND for a clinical-stage drug company is a crucial step in the development lifecycle of a product, as a favorable safety profile needs to be...
by Heather Gillman | Apr 28, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Gerald L. Klein, Roger E. Morgan, Melissa Palmer, Jamie Lazar, Freddy Byrth, Wayne M. Dankner, Jamison Chang, John Hinkle, Jim Sergi Corresponding author: Gerald L. Klein, gklein@medsurgpi.com ABSTRACT A Data and Safety...
by Heather Gillman | Apr 10, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Jose Madrid, MHA, MBA and Janice Cattano, RN, MSN On February 2, 2026, the US Food and Drug Administration’s (FDA) medical device Quality Management System Regulation (QMSR) went into effect, replacing the Quality...
by Heather Gillman | Oct 17, 2025 | News, Press Releases
Phase Advance and QNova Capital Forge Alliance to Usher in AI-Driven, Non-Animal Drug Development Era Predictive AI modeling startup and biotech-focused venture fund unite to accelerate next-generation therapeutics and reshape the FDA regulatory path. SAN DIEGO, CA,...
by Heather Gillman | Sep 3, 2025 | News, Press Releases
Aiming to Accelerate Market Launch with a Track Record of 100% FDA Approval Success August 26 , 2025—OrganTech Inc. (Head Office: Chuo-ku, Tokyo; CEO: Yoshio Shimo; hereinafter “OrganTech”), engaged in the world’s first application of organ regeneration technology* to...
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