The pace of regulatory change in life sciences is accelerating, and few areas reflect that more clearly than oncology. Project Orbis, an initiative led by the FDA’s Oncology Center of Excellence, offers a real-time case study in how regulatory content submission and generation are evolving.
For this discussion, we spoke with a seasoned global labeling and regulatory affairs leader who has guided strategy at several top multinational pharmaceutical companies. A trained pharmacist with hands-on experience managing submissions under Project Orbis and other high-velocity programs, they bring a rare blend of frontline clinical insight and strategic expertise in global labeling, compliance, and cross-market submissions.
With its emphasis on simultaneous, multi-agency reviews, Orbis has become a proving ground for how companies manage global label development under pressure. Its core principles—collaboration, structured content, faster cycle times, and regulatory trust—are increasingly relevant across therapeutic areas.
In this Q&A, our guest shares first-hand strategies for navigating accelerated timelines, aligning across multiple agencies, and leveraging automation to keep pace with today’s regulatory demands.
Q: How have you seen the submission process for oncology labels change over the last few years?
A: Oncology has always moved quickly, but today’s timelines are even more compressed. Label content often needs to be ready before final clinical data is locked. That means cross-functional teams are writing, reviewing, and aligning content in parallel with study closeout. It’s no longer just about pre-approved phrases—it’s about upstream coordination across global stakeholders to ensure the label is synchronized before submission even begins.
Q: What has Project Orbis changed in terms of label submission strategy?
A: The biggest shift is the collaborative nature of submission review. With Orbis, you’re able to capitalize on multi-agency negotiations instead of stand-alone negotiations per county. This helps streamline feedback and the approval cycle, helping foster timely approvals and labeling consistency. The challenge is aligning on content in real time, across time zones and regulatory expectations, while under extreme deadline pressure.
Q: Do you see the Project Orbis model being applied beyond oncology?
A: I think it’s only a matter of time. The concept of simultaneous review is valuable anywhere speed to market matters—rare diseases, gene therapies, even high-priority infectious diseases. Orbis has proven that collaboration can shorten timelines without compromising quality. But it also raises the bar: your content needs to be solid and synchronized upfront. Structured content management gives companies a clear advantage in that environment.
Q: Are there operational changes companies have made to meet these demands?
A: Yes. The most successful companies start planning much earlier, sometimes before pivotal trials are read out. They also rely on structured authoring environments. If your label content lives in static Word files emailed across regions, you won’t keep up. A structured core label that’s centrally maintained and locally adaptable is now the standard. It supports traceability, reduces duplication, and accelerates alignment.
Q: What roles do technology and content management play in accelerating timelines?
A: Structured content and automation are essential. When you can reuse approved phrases, generate health authority-specific outputs like SPL or ePI with minimal manual work, and track all versions and rationales, your submission process becomes exponentially faster. AI and content intelligence also help reduce the burden on humans working under tight timelines by assisting with quality control and flagging inconsistencies before they go out the door.
Q: How should companies balance global consistency with local regulatory requirements?
A: Governance is key. You need a global framework that defines which elements are mandatory and which can be adapted. Local teams should have a structured way to propose deviations, with justifications tracked. That allows for transparency while preserving the integrity of a global label. It also makes reconciliation during multi-agency review much more efficient.
Q: What’s one piece of advice you’d give to regulatory teams preparing for their first Orbis submission?
A: Start earlier than you think you need to. Engage affiliates early. Don’t wait for final data to begin aligning on content. And if you haven’t adopted structured content or labeling automation, this is the time. When the clock starts on an Orbis submission, sometimes with just 10 weeks to prepare, you won’t have time to chase edits or resolve misalignments manually.
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Conclusion
Project Orbis represents more than a faster review timeline; it signals a new model of regulatory collaboration and trust. With shared dossier development, synchronized timelines, and real-time agency engagement, the pressure on labeling teams is immense. But with that pressure comes opportunity: companies that invest in structured content, automation, and global governance are positioning themselves to thrive in the future of regulatory operations.
At Glemser, we’re continuously learning from industry experts like the one featured here. These insights help us shape our solutions to support highly regulated, cross-functional teams working under accelerated conditions. Whether you’re managing Orbis submissions or expanding structured content for global use, we can help you meet the moment, with proven solutions already in use at top-20 pharma companies.
Want to see how we’re supporting regulatory teams through labeling acceleration, automation, and global content reuse? Contact Glemser to get started.