IP Risk: Protecting Regulatory Data Like Trade Secrets

In the pharmaceutical world, the term “regulatory submission” sounds procedural—like it’s just the paperwork that comes after the real work is done.

But let’s be clear: Your regulatory data is the work.

Sensitive data is valuable data on several different levels

It’s the culmination of years of collaboration and research, millions in investment, and your company’s best shot at securing market authorization. And yet, for something so foundational, it’s still often left exposed, scattered across shared folders, emailed as attachments, or siloed in systems with outdated access controls.  So much hard work went into the research and discovery, yet very little attention was paid to protecting your most valuable pharma data.

Here’s the uncomfortable truth: The way life sciences companies handle regulatory data would never fly if we treated it like the very valuable trade secret it actually is.

Regulatory Data Is IP

When tech giants guard their source code, no one questions it. When consumer companies lock down product formulas, that’s just smart business. But in life sciences? The data that drives your patent protection, your approval timeline, and your competitive edge often gets passed around like it’s just another file, without enough worry about compliance or data security.

Regulatory data should be treated with the same precision as proprietary algorithms or core formulas, because it is your differentiator. Not sure?

Think about what’s actually in these documents:

• Clinical trial designs and endpoints

• Safety and efficacy data

• Manufacturing processes

• Labeling strategies

• Drug substance and product details

• Correspondence and meeting minutes with regulators

Together, these materials form the blueprint of your product and your path to exclusivity.

So why aren't we protecting it as we mean it?

The Data Protection Risks Are Real, And Growing

The regulatory process is inherently collaborative. Internal teams, external consultants, submission vendors, and regulatory authorities all need access at various points. That complexity increases the chances of data being mishandled, misused, or outright stolen.

As global privacy regulations evolve, submission packages often contain sensitive patient data subject to strict rules.

Here’s where the cracks start to show:

• Submissions stored without classification or protection

• No audit trail of who accessed what and when

• Inability to revoke access once files are shared externally

• Encryption, if applied, is file-based and doesn't allow for collaboration

If that sounds familiar, you're not alone. And that’s exactly where the opportunity lies.

The Missing Control Layer

The gap isn’t visibility or policy. It’s the absence of enforceable controls at the data layer. To address this, organizations must move toward protecting sensitive unstructured data that persists regardless of where a file is stored or who holds it.

Data-Centric Protection for Regulatory Integrity

Imagine a platform that not only helps you manage regulatory data but also protects it as an asset.

With data-centric protection, sensitive documents are secured at the file level, regardless of where they move, whether to an on-premises data store or a cloud destination.

• Files are automatically identified and classified based on content

• Encryption is applied at creation, and access rights are embedded into the metadata

• You control who can open and view your data—and when

• Access can be revoked remotely—even after a file has been downloaded

This approach ensures confidentiality and integrity throughout the data’s lifecycle—before, during, and after submission. It also means you’re not relying on third-party platforms or email attachments to protect your most sensitive IP.

Because the second you submit it, that data becomes an extension of your brand...and your risk.

Submissions Deserve More Than a “Send”

Regulatory documents are not just checkboxes on a timeline. They are your company’s scientific evidence, IP strategy, and licensing potential all in one.

If you wouldn’t publish your NDA filing or clinical study report on the internet for competitors to see, then why accept anything less than end-to-end protection?

This isn’t about slowing down—it’s about moving forward with confidence. Because keeping your regulatory data secure doesn’t just reduce risk—it protects your future.

👉 See how we help pharma protect its most sensitive regulatory data

Or, contact us for a demo.