Case Study: Bachem (leading peptide & oligonucleotide CMO) achieves rapid, centralized regulatory management — from days to minutes — with Ennov RIM

Flexibility is Key to Providing a Game-Changing RIM Solution for a Contract Manufacturing Organization

Bachem Americas, the regulatory team of global CMO Bachem, faced growing complexity managing Drug Master Files, IND technical packages and other registrations using spreadsheets and scattered folders while staff rotated across projects. Many vendors lacked RIM solutions tailored to an API contract manufacturer, so Bachem evaluated and selected Ennov’s RIM (including a no-commitment sandbox) to find a flexible partner that could meet their specific regulatory use cases.

Ennov worked closely with Bachem to configure Ennov RIM, migrate and cleanse data manually, and redefine workflows for efficiency; the project launched on time and on budget with smooth validation. The new Ennov RIM eliminated about 20 spreadsheet trackers, standardized vocabularies and workflows, and delivered dramatic time savings—historical submission pulls that once took a week now take 10 minutes or less, and a container/closure lookup that used to take a day now takes five minutes—improving customer service and enabling a more proactive regulatory team.

Bachem

Jamie Brugnano

Senior Manager