For Regulatory Operations Leaders: Building a Technology Strategy That Scales
If you lead regulatory operations at a growing pharma or biotech company, you have likely been handed a mandate that sounds simple and is not: modernize the technology stack, reduce submission cycle times, and do it without disrupting the work that is already in flight. The temptation is to start with a vendor evaluation. The better move is to start with a strategy.
What follows is not a product recommendation. It is a framework for making technology decisions that hold up under the pressure of growing pipelines, expanding regional filings, and the inevitable organizational changes that come with scale.
1. Start With Workflow, Not Features
Before you evaluate a single vendor, map your actual submission workflow from end to end. Not the idealized process in your SOP — the real one. Where do documents sit waiting for someone to act? Where do people re-key data from one system into another? Where do errors originate, and where are they discovered?
Most organizations find that their biggest time losses are not in any single step but in the transitions between steps: the export from the publishing tool, the upload into the review platform, the manual update to the tracking spreadsheet, the email thread asking whether this is the final version. These handoffs are invisible in a feature comparison matrix, but they are where weeks disappear from your submission timeline.
When you understand your workflow gaps, your technology requirements write themselves. You stop evaluating whether a tool has a particular feature and start evaluating whether it eliminates a particular bottleneck.
2. Integration Over Best-of-Breed
The regulatory technology market has historically rewarded specialization. One vendor for publishing. Another for review. A third for regulatory information management. A fourth for document management. Each tool may be excellent in isolation. Together, they create a workflow that is held together by manual processes, file exports, and institutional knowledge about which system is the source of truth for which data.
The cost of this fragmentation is not just operational. It is strategic. When your submission data lives in four systems, you cannot answer basic questions without significant manual effort: How long does our average submission cycle take? What is our first-time acceptance rate? Where do our QC errors cluster?
Platforms that cover publishing, review, and planning in a single system eliminate the integration tax. If a single-platform approach is not feasible for your organization, the minimum requirement should be open APIs that allow real-time data exchange. Bi-directional synchronization with your eDMS — whether that is Veeva Vault, SharePoint, or another system — is not a nice-to-have. It is the foundation of a workflow that does not depend on manual file transfers. REST APIs that expose submission data to your internal systems enable dashboards, analytics, and automation that would be impossible with siloed tools.
3. Right-Size Your Investment
There is a meaningful difference between what a 150-person biotech with three products in development needs and what a top-10 pharma company with hundreds of active registrations requires. The enterprise RIM platforms serve a purpose at the upper end of that spectrum, but they carry enterprise-grade complexity, implementation timelines, and cost structures.
If your primary need today is publishing and review — getting submissions out the door accurately and on time — evaluate platforms built for that purpose. You can always expand scope later. What you cannot easily do is recover the eighteen months and seven-figure budget spent implementing a system whose capabilities far exceed your current requirements.
Ask yourself an honest question: do you need a regulatory information management suite, or do you need a publishing and review platform that actually works? The answer determines which category of vendor you should be talking to.
4. Plan for eCTD 4.0
The transition from eCTD 3.x to eCTD 4.0 — built on the HL7 Regulated Product Submission standard — is not imminent, but it is inevitable. The architectural implications are significant: a shift from file-system-based packaging to structured data exchange, from PDF-centric documents to potentially richer content models, from regional variations bolted onto a common structure to a natively multi-regional framework.
Any platform you adopt today should have a credible eCTD 4.0 roadmap. This does not mean the platform needs to support 4.0 today — no agency is accepting 4.0 submissions yet. It means the platform’s architecture should be capable of accommodating the transition without requiring a complete rebuild. Cloud-native platforms with modular architectures have a structural advantage here over monolithic on-premise tools.
Ask your vendor specifically: what is your 4.0 development timeline, and what architectural changes will be required? If the answer is vague, that is information.
5. Validate Once, Benefit Continuously
Validation is one of the most underestimated costs in regulatory technology. On-premise tools require validation at installation and revalidation with every major upgrade. If your publishing tool releases two major versions per year, you are running validation cycles semi-annually — each one consuming weeks of your quality team’s time and creating a perverse incentive to delay upgrades and fall behind on functionality and security patches.
Cloud-native platforms with a pre-validated deployment model change this equation. The vendor maintains the validated state of the infrastructure. IQ/OQ/PQ packages are provided as part of the service and updated with each release. Your quality team executes the customer-specific validation activities once and receives continuous platform improvements without repeating the full cycle.
This is not a minor operational detail. It is a strategic advantage that compounds over time. The organization running a validated cloud platform is always on the current version. The organization maintaining an on-premise tool is always negotiating between the version they want and the validation effort required to get there.
6. Measure What Matters
You cannot improve what you do not measure, and most regulatory operations teams measure very little about their own performance. Consider whether you can currently answer the following questions with data rather than estimates:
- Submission cycle time: From planning initiation to gateway acceptance, how many calendar days does your average submission require?
- First-time acceptance rate: What percentage of your submissions are accepted at the gateway without technical rejection?
- QC cycle duration: How many review cycles does a typical submission require before QC sign-off?
- Hyperlink error rate: What percentage of hyperlinks in your published submissions are broken or incorrectly targeted?
- Agency response time: How quickly does your team process and respond to agency correspondence?
If your current tools cannot provide these metrics, that is a data point in itself. A platform that captures submission data end-to-end — from planning through publishing, review, and post-submission correspondence — can generate these metrics as a byproduct of normal operations. They do not require a separate analytics project or a consultant engagement. They exist because the data exists.
When you have these numbers, technology investment decisions become significantly easier to justify. A platform that reduces your submission cycle time by two weeks across fifty annual submissions has a quantifiable value. A platform that improves your first-time acceptance rate from 90% to 98% has a quantifiable value. Executive sponsors respond to these numbers in a way they do not respond to feature lists.
The Strategy That Scales
The best regulatory technology strategy is not the most expensive one. It is not the one with the longest feature list or the most recognizable vendor name. It is the one that matches your team’s actual needs today, solves the workflow problems that are costing you time and quality, and scales with your pipeline as it grows.
Start with your workflow. Identify the handoffs and bottlenecks that consume disproportionate effort. Evaluate platforms that eliminate those specific problems. Require open APIs and integration capabilities so your choice today does not become a constraint tomorrow. Validate efficiently so your quality team supports technology adoption rather than resisting it. Measure your performance so you can demonstrate the return on your investment.
The organizations that get this right do not just file submissions faster. They build a regulatory operations capability that becomes a competitive advantage — one that attracts talent, supports business development, and gives leadership confidence that the regulatory function can keep pace with the science.
