03.26.25 -- MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs

The FDA's new FAQ offers crucial insights into best practices, from regulatory meetings to quality control and preclinical studies. Dive in for expert guidance.

Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.

Explore Annex 1 updates on contamination control in pharmaceutical cleanrooms, emphasizing cleaning consistency, training, advanced tools, and technologies to achieve regulatory compliance.

Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of movements over and over.

Avoid FDA recalls and safeguard your life sciences business. Learn how QMS and EBR/eDHR solutions can prevent costly product recalls and ensure compliance with FDA regulations.