Archive for category: Regulatory

Preparing for IDMP: Insights from the Gens & Associates survey

Josh Keliher, January 19, 2021, Regulatory

Recently, I reviewed the results of the Gens &...

Managing post-approval CMC changes with RIM & QMS

Sean Carpenter, December 23, 2019, Quality, Regulatory

Perhaps no aspect of Regulatory Information Manage...

FDA Eliminates the need for Paper Device Submissions

Sean Carpenter, December 18, 2019, Regulatory

Recently, the FDA issued a final rule to amend reg...

Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures

Sean Carpenter, October 10, 2019, Regulatory

Most people think of Regulatory Information Manage...

Ennov User Group Meeting takes on New Orleans

Phillip Strickland, May 2, 2018, Clinical, Pharmacovigilance, Quality, Regulatory

The 2018 Ennov User Group Meeting was recently hel...

Headquartered in Paris, with offices in Greensboro, NC, Durham, NC and Cambridge, UK, Ennov makes the most cost effective, comprehensive, and user-friendly solutions for regulated content management. We’re proud to serve over 500 customers with a total of 250,000 users, ranging from leading pharmaceutical companies to emerging biotechnology companies throughout the Life Sciences industry.