News & Events

Ennov and fme Life Sciences Announce New Partnership

fme Life Sciences to offer enterprise content and data management services in support of Ennov’s Regulatory solution suite. Ennov and global professional services firm fme Life Sciences are pleased to announce a new partnership that will provide an expanded portfolio

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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

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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

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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

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Ennov Recognized by Garner in Multiple 2019 Research Reports

Ennov announces its inclusion in four 2019 Life Science market research reports published by Gartner, Inc. the leading information technology research and advisory company.  The following reports recognize Ennov solutions: Hype Cycle for Life Science Research and Development Hype Cycle

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