Increase Efficiency And Reduce Risk With A Molecule-To-Market Action Plan

By Michel Denarié, Senior Principal, Regulatory Affairs and Drug Development Solutions (RADDS), and Michelle Gyzen, Senior Director, Regulatory Affairs and Drug Development Solutions (RADDS)

Bringing your drug from molecule to market necessitates expert navigation of the clinical development landscape and its accompanying regulatory systems. Though a drug sponsor may struggle to identify their best indication for drug development or to meet regulatory expectations, the decision to outsource may initially appear daunting as well. However, with careful collaboration and planning, the right outsourcing partner can help you build a streamlined drug development process. Begin your search by familiarizing yourself with the moving parts required to build a scalable, effective outsourcing model.

IQVIA’s Regulatory Affairs and Drug Development Solutions (RADDS) group assists companies with their clinical development and regulatory processes from discovery to commercial availability. RADDS equips your team with access to a bespoke outsourcing model designed to drive existing organizational efficiencies. Throughout the process, IQVIA staff provides extensive support, including regulatory intelligence, investigational new drug (IND) application strategies, early- and late-stage gap analyses, market expansion, technology access, and more. Download the complete whitepaper to explore the benefits of end-to-end regulatory engagement via an illustrative case study.