Month: December 2019

Managing post-approval CMC changes with RIM & QMS

Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes.  A wide variety of stakeholders are involved, from manufacturing/supply change to corporate quality to regulatory affairs and regulatory operations. A diverse set of independent or loosely integrated systems are involved: Enterprise

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Optimize Your eTMF Strategy

I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11). I wanted to give you in this blog a short glimpse on the main points addressed in

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FDA Eliminates the need for Paper Device Submissions

Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will submit a single submission in electronic format. Because a medical device premarket submission in electronic format is easily reproducible, the

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