IPEC is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with our counterparts in Europe, China and Japan serves as primary international resource on excipients for its members, governments and public audiences. more>
IPEC-Americas’ written comments were submitted to FDA on November 2, 2015
A real-world, participative workshop designed to help you understand and apply the concepts of QbD as they relate to excipient variability.
Every regulatory professional should know the standards, groundwork, expertise and technology required to submit compliant eCTD submissions to FDA.