Lately, I’ve been reflecting on how often companies underestimate the complexity of global regulatory submissions. Everyone’s trying to move fast—but fast doesn’t always mean strategic. And honestly, it’s not the big, obvious challenges that cause trouble. The smaller, overlooked assumptions end up delaying launches or putting compliance at risk.
After years of working with clients expanding into new markets—and leading those submissions myself across various regions—I’ve noticed certain patterns that come up time and again. These risks don’t make it into the slide decks, but they can cost you time, credibility, and access if you don't plan for them.
Take harmonization, for example. On paper, we all know about IMDRF, GHTF, and reliance frameworks, and there’s a tendency to assume that means you can replicate a submission package across multiple markets. But in practice, each authority applies its own interpretation. A dossier that passes under EU MDR might need a full overhaul before submission to AMAR in Israel or MFDS in Korea. Local formatting rules, language requirements, and regulators' interpretation of risk classification are rarely fully aligned.
Another common pitfall: assuming that if you submit to several countries at once, you’ll get approvals around the same time. That rarely happens. Timelines drift between agency workloads, how they handle completeness checks, and even the time they take to review translations. It’s subtle at first, but it snowballs. I always recommend using up-to-date data and current trends—not outdated timelines from a folder that hasn’t been updated in years. And always, always build in buffer time for follow-up questions and clarifications.
Documentation reuse is another trap. Having a strong core dossier is smart—but I’ve seen too many teams fall into the habit of copy-pasting from EU or US files without adjusting for local expectations. Labelling alone can trigger major issues. What works in one market might be non-compliant in another. Each submission needs a strategic review, not just administrative formatting.
Then there’s internal communication—or often, the lack of it. Regulatory teams are frequently brought in late when a product is already on the verge of launch. By then, aligning on strategy or making last-minute changes is more about damage control. I’ve found that introducing structured compliance checkpoints works well, especially between RA and commercial or operations teams. It’s a simple step, but it makes a big difference.
I’ll also say this: spreadsheets are not enough. Manual submission tracking is common, especially in smaller companies, but it can lead to version control issues, missed deadlines, and audit stress. You don’t need a huge system, but a centralized RIM tool or shared dashboard can go a long way in keeping everything on track.
And finally, post-approval. This often gets treated as an afterthought, but each market has its own post-market surveillance requirements—from clinical follow-up to vigilance reporting. You'll be scrambling later if you don’t plan for this during the submission phase. It’s far easier to build it into your process upfront than try to retrofit it after launch.
So yes, expanding globally is exciting—but it’s not just about speed. It’s about building a system that works: one that’s robust enough to scale yet flexible enough to adapt. That’s the approach I bring to every client I support—helping them grow smart, not just fast.
If you’re a regulatory professional handling submissions across different markets, you already know the workload is heavy—and it rarely runs smoothly without the right tools. Arazy Group’s LICENSALE® and REGISLATE® platforms were built to make your life easier. Whether opening up new markets or managing existing approvals, we help you stay ahead of shifting requirements and avoid costly surprises. If you’re looking for more intelligent systems to support your team and take some pressure off, we’d love to show you what we can do.
Imane Jemal, Arazy Group