\nFor over 70 years, the Geneva-based biotech OM Pharma has been a global leader in preventing recurrent respiratory and urinary tract infections, alongside developing vascular disease medicines. As the company launched new clinical trials globally in 2021, siloed regulatory information management (RIM) systems and fragmented processes limited visibility into submission progress. This hindered accurate workload forecasting and made it difficult to strategically plan with data.\n<\/p>\n
\nOM Pharma relied on four disconnected databases to manage critical regulatory functions: its document library, submission tracking, eCTD publishing, and EudraVigilance Medicinal Product Directory (XEVMPD) submissions. Teams lacked confidence in data quality and spent significant time retrieving and checking critical information, leading to operational bottlenecks. To deliver on its global goals, OM Pharma required a solution that would scale and increase regulatory operational efficiency while maintaining compliance.\n<\/p>\n
\nIn March 2022, the company harmonized data across the organization and streamlined regulatory processes with ³Ô¹Ï±¬ÁÏ Registrations<\/a> and ³Ô¹Ï±¬ÁÏ Submissions<\/a> as part of ³Ô¹Ï±¬ÁÏ RIM<\/a>. \u201cWe decided to switch for better visibility, to be better prepared and manage our workloads, and enhance flexibility,\u201d says Kamal el Bakali, regulatory operations team lead at OM Pharma. The shift to a single unified RIM platform also helped eliminate the high cost of maintaining and manually updating multiple databases.\n<\/p>\n \n\u201cThe greatest advantage of ³Ô¹Ï±¬ÁÏ RIM is to have everything in one system,\u201d says el Bakali. \u201cNow we have confidence in our data because it is in one place.\u201d The regulatory function led the implementation, working with stakeholders across quality and IT to drive critical decision-making. The team’s top priority during the migration was accurately mapping data from the multiple legacy databases to the new system. el Bakali noted that success depended on assigning a dedicated project manager to oversee the data mapping effort.\n<\/p>\n \nWith a single source of truth for regulatory data and documents, OM Pharma leveraged ³Ô¹Ï±¬ÁÏ submission content plans<\/a> (SCPs) as \u201cthe central element of our submission process,\u201d says el Bakali. Its regulatory team uses SCPs to unify relevant content and processes for streamlined submission lifecycle management. This capability improves process governance and makes compliance easier. \u201cThe whole regulatory process from document creation to final submission is now a smooth, easy-to-follow transition within ³Ô¹Ï±¬ÁÏ RIM. We do everything inside: document creation from templates, content approval via workflow, and direct placement into the submission content plan,\u201d says el Bakali. \u201cFor us, this was a very important improvement compared to previous solutions.\u201d\n<\/p>\n \n\u201cI suggest using submission content plans from the very beginning because when you get used to its functionality, it is very easy to switch to ³Ô¹Ï±¬ÁÏ Submissions Publishing.\u201d \nSince SCPs can manage the entire publishing process, OM Pharma took the opportunity to accelerate submission preparation and delivery, with higher quality content and messaging. In April 2025, the company implemented ³Ô¹Ï±¬ÁÏ Submissions Publishing<\/a> and ³Ô¹Ï±¬ÁÏ Submissions Archive<\/a>. With continuous publishing<\/a>, OM Pharma pulls traditionally downstream publishing and validation tasks upstream to run in parallel with submission content planning and authoring.\n<\/p>\n \nThe transition to continuous publishing was seamless for OM Pharma\u2019s regulatory team. \u201cI suggest using submission content plans from the very beginning because when you get used to its functionality, it is very easy to switch and take advantage of ³Ô¹Ï±¬ÁÏ Submissions Publishing,\u201d el Bakali emphasizes. \u201cWe see that the process is now going faster for publishing.\u201d Publishers also gain more responsibility earlier in the process, leveraging health authority-compliant SCP templates with recommended constraints for both eCTD and non-eCTD formats.\n<\/p>\n \nWithin just two months of the implementation, OM Pharma used ³Ô¹Ï±¬ÁÏ Submissions Publishing to submit to Switzerland, other countries within Europe, DACH, and the USA. With a unified RIM platform, the company is positioned to seamlessly scale across regions and navigate evolving global health authority requirements like eCTD 4.0 and IDMP<\/a>.\n<\/p>\n
\n– Kamal el Bakali, Regulatory Operations Team Lead, OM Pharma<\/span>\n<\/p><\/blockquote>\nAccelerating global and regional submissions at scale<\/h2>\n