OM Pharma Scales Globally by Harmonizing Data with Unified RIM

For 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.

OM 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.

Improving data and process governance with unified RIM

In March 2022, the company harmonized data across the organization and streamlined regulatory processes with Veeva Registrations and Veeva Submissions as part of Veeva RIM. “We decided to switch for better visibility, to be better prepared and manage our workloads, and enhance flexibility,” 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.

“The greatest advantage of Veeva RIM is to have everything in one system,” says el Bakali. “Now we have confidence in our data because it is in one place.” 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.

With a single source of truth for regulatory data and documents, OM Pharma leveraged Veeva submission content plans (SCPs) as “the central element of our submission process,” 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. “The whole regulatory process from document creation to final submission is now a smooth, easy-to-follow transition within Veeva RIM. We do everything inside: document creation from templates, content approval via workflow, and direct placement into the submission content plan,” says el Bakali. “For us, this was a very important improvement compared to previous solutions.”

“I suggest using submission content plans from the very beginning because when you get used to its functionality, it is very easy to switch to Veeva Submissions Publishing.” – Kamal el Bakali, Regulatory Operations Team Lead, OM Pharma

Accelerating global and regional submissions at scale

Since 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 Veeva Submissions Publishing and Veeva Submissions Archive. With continuous publishing, OM Pharma pulls traditionally downstream publishing and validation tasks upstream to run in parallel with submission content planning and authoring.

The transition to continuous publishing was seamless for OM Pharma’s regulatory team. “I 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 Veeva Submissions Publishing,” el Bakali emphasizes. “We see that the process is now going faster for publishing.” 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.

Within just two months of the implementation, OM Pharma used Veeva 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.

Learn more about continuous publishing by visiting our resource hub.