Baily Thomas
Baily Thomas PharmD, is Regulatory Strategist, Global Regulatory Affairs, Specialty Care, at Sanofi, Bridgewater, NJ, USA.
JournalInnovating and harmonising access and requirements amid the global regulatory challenges of biologics
This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...