Ensuring Quality And Regulatory Compliance In Outsourced Manufacturing

This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” outlines how sponsors can ensure that a CDMO’s quality systems and analytical outputs meet regulatory expectations by aligning early on target regions, building audit and qualification rights into contracts, executing robust quality agreements, monitoring QMS metrics, and overseeing third-party testing vendors, featuring panelist April Loui, SVP Quality and CMC Regulatory at ReCode Therapeutics, as well as Founder, CEO at Clarity Global Pharma, with additional insights from Thierry Bilbault, Co-founder and Principal at JT Biopharma Partners, and Natalie Farris, Executive CMC Consultant at Naltou Pharma CMC Consulting, LLC.