November 27, 2024

Knowing how serious the Part 11 of Title 21 CFR regulations of the FDA are, is the best way to ensure integrity and trust in

FDA Issues New Guidance for the Conduct of DCTs  The Food and Drug Administration (FDA) has recently released new guidance on the conduct of decentralized

Technology Transfer is an essential aspect for the pharmaceutical and biotechnology field as it allows effective transfer of knowledge, processes, and breakthroughs engineering from research

Effective management of returned drug products is an essential part of pharmaceutical operations, necessitating complex activities to safeguard patients, as well as the pharmaceutical supply

Recent years have seen the emergence of a promising newcomer to the cancer immunotherapy landscape – Chimeric Antigen Receptor (CAR) T-cell therapy. CHMP has paved

Learn about the complexities of returned drug product law and why it is critical for pharmaceutical manufacturers, distributors and pharmacy staff.  Returned Drug Product Regulation: 

Explore the fundamental regulatory considerations for mRNA vaccine variants, focusing on the key elements and approaches used by quality and regulatory consulting firms to guarantee

The Quality System File is the foundation for compliance with the FDA Quality System Regulation (QSR), found in Part 820. Such a repository is the