Regulatory Services For Accelerated Development And Commercialization

The increase in breakthrough therapy designations and other allowances for expedited regulatory review has led to ever more innovative drug products being developed under shortened timelines. Accelerated development can be particularly challenging for small and emerging biotech companies with limited resources in-house. These companies often seek support from external partners, including contract development & manufacturing organizations (CDMOs). Jakob Bonde, Head of Regulatory Affairs, Small Molecules at Lonza, discusses how the company helps customers navigate today’s regulatory environment, while shortening timelines to clinical trials and commercialization.