Is Your Regulatory Operations Infrastructure Ready for What’s Next?
If you oversee regulatory operations at a pharma or biotech company today, there is a reasonable chance your core infrastructure was selected during a different era. The publishing tool your team relies on was likely implemented five to ten years ago. Your document management system may predate your current organizational structure. The integrations between systems — if they exist at all — were built as one-off projects with handoffs that still require manual intervention.
For years, this was adequate. Submission volumes were manageable. Regulatory expectations were stable. The eCTD format, while imperfect, was well understood. Teams could absorb inefficiency because the pace of work allowed it.
That calculus is changing.
The Pressure Is Compounding
Several forces are converging on regulatory operations simultaneously. eCTD 4.0 is no longer a distant talking point — it represents a fundamental shift in how submission content is structured, validated, and exchanged with health authorities. Submission volumes are increasing as pipelines diversify across therapeutic areas and geographies. Regulators themselves are raising the bar on data quality, expecting cleaner metadata, more consistent formatting, and faster turnaround on agency questions.
Meanwhile, the operational reality inside most organizations has not kept pace. Teams are asked to do more with the same headcount. Knowledge is concentrated in a few senior specialists. Processes are documented in SOPs but executed through tribal knowledge and workarounds.
The question every Senior Director should be asking is not whether their current setup works today, but whether it can absorb what is coming in the next two to three years.
Five Questions Worth Asking Now
1. Can your current tools scale without scaling your team?
If adding a new market or increasing submission frequency requires proportional headcount growth, your infrastructure is a bottleneck. Modern regulatory operations should be able to absorb incremental volume through automation — not additional FTEs. Consider how much of your team’s time is spent on repetitive, rules-based work: hyperlink validation, PDF formatting checks, folder structure creation, metadata entry. Every hour spent on tasks that could be automated is an hour unavailable for strategic work.
2. Are your processes automated or just documented?
There is a significant difference between having an SOP for quality control and having a system that enforces quality control automatically. Many organizations conflate documentation with automation. A well-written SOP that describes a fifteen-step manual QC process is still a fifteen-step manual QC process. The goal should be to reduce the number of steps that require human judgment, not simply to describe the steps more precisely.
3. Do your systems talk to each other?
Regulatory operations typically spans publishing, document management, regulatory information management, and planning. In most organizations, these are separate systems with limited integration. Data is re-entered across platforms. Version discrepancies go undetected until late in the process. Submission planners and publishers operate from different sources of truth. If your team spends meaningful time reconciling information between systems, your architecture is working against you.
4. Can you onboard a CRO without a six-week IT project?
Outsourcing is a permanent feature of regulatory operations. Whether you use CROs for overflow publishing, regional filings, or full submission management, the ability to integrate external partners quickly and securely is essential. If bringing a CRO into your workflow requires VPN provisioning, local software installation, and weeks of configuration, your collaboration model is a liability. Cloud-native platforms with role-based access and built-in review workflows should make external collaboration a configuration decision, not an IT initiative.
5. Is your infrastructure a fixed cost or a flexible capability?
On-premise publishing environments carry substantial overhead: server maintenance, software updates, license management, and dedicated IT support. For mid-size companies in particular, this fixed cost structure limits agility. A cloud-based model shifts infrastructure from capital expenditure to operating expenditure and removes the maintenance burden from internal teams. More importantly, it enables continuous improvement — updates happen in the background, not during scheduled downtime windows.
What Readiness Actually Looks Like
Infrastructure readiness is not about having the newest technology for its own sake. It is about ensuring that your regulatory operations function can respond to changing demands without heroic individual effort. It means your publishing environment handles validation automatically. It means your review workflows are integrated with your authoring and planning tools. It means your data is structured, accessible, and governed.
This is the design philosophy behind DnXT. Rather than layering automation onto legacy architectures, DnXT was built as an integrated, cloud-native platform that unifies publishing, review, and planning in a single environment. Automated QC runs continuously, not as a final gate. CROs and internal teams work in the same workspace with appropriate access controls. eCTD output is validated in real time as content is assembled, not after the fact.
The result is an operations infrastructure that scales with your submission volume, not your headcount.
The Cost of Waiting
Infrastructure decisions in regulatory operations tend to be sticky. Migration is disruptive, and the switching costs are real. That is precisely why the right time to evaluate your readiness is before you hit a capacity wall — not after a critical submission is delayed because your tools could not keep up.
The organizations that will navigate eCTD 4.0, expanding global portfolios, and increasing regulatory scrutiny most effectively are the ones making infrastructure decisions now with a clear view of what the next five years demand.
The question is not whether change is coming. It is whether your infrastructure will be ready when it arrives.
