The Hidden Costs of Building a Regulatory Publishing Function

When smaller pharma and biotech organizations reach the point of regulatory submission planning, there’s often a pivotal decision to make: do we build an internal publishing capability or outsource? On paper, growing the team internally seems logical, especially if there is a steady pipeline, experienced regulatory leads, or a desire to maintain direct control.

In-house publishing can make sense when organizations have high submission volume, a stable pipeline, and a dedicated internal team with the budget to support ongoing validation, training, and system maintenance.

What most teams underestimate, however, is that the true cost of publishing isn’t in the submission files. It’s in the infrastructure required to produce them consistently, accurately, and compliantly over time. And that infrastructure is significantly more complex than assembling a few templates or training someone on eCTD submission tools.

In reality, building a publishing capability means taking on the obligation to train personnel, maintain systems, enforce documentation governance, track every change, ensure traceability, manage updates, and remain audit-ready, not just at submission deadlines, but every day.

The Most Common Misconception

“Once we hire a publisher or train someone, we’ll be fine.”

This belief usually emerges at a predictable moment. A team is preparing for an IND. A regulatory lead suddenly finds themselves juggling multiple authors. Perhaps investors are asking about readiness for upcoming milestones. Maybe the organization has a growing pipeline, and leadership assumes publishing volume will be steady and manageable. At this stage, it’s very common to assume that publishing is a simple, administrative task focused on formatting and creating PDFs.

In each of these situations, the team may be reacting to a short-term pressure point and looking for a quick fix. Hiring one person or training an existing team member feels like the most efficient solution.

But regulatory publishing isn’t a task. It’s a controlled process. A single submission can involve hundreds of documents, multiple authors, shifting timelines, and ongoing data updates. The moment you bring publishing in-house, you’re also taking on the obligation to maintain a compliant infrastructure.

That distinction is where most teams underestimate the true cost. The perceived short-term convenience of “we’ll just bring it inside” often leads to long-term operational and compliance challenges that only become visible when deadlines tighten, or regulators start asking questions.

What It Really Takes to Build a Publishing Capability

A publishing function needs more than personnel. It requires:

What’s Needed	Why It Matters
A validated publishing system (software, hosting, compliance maintenance)	Must meet data integrity and traceability expectations.
SOPs and work instructions	Required for consistency, training, and regulatory inspection.
Role definitions and RACI alignment	Ensures separation of responsibilities and accountability.
Formal QC workflows	Reduces risk of versioning errors and incomplete submissions.
Metadata, document naming, and versioning structure	Required so all documents can be tracked, retrieved, and verified.
Change control documentation	Mandatory if tools or processes evolve in regulated environments.
Ongoing training records	Must prove publishing staff are qualified, up-to-date, and trained per process.
System updates and maintenance	Regulatory requirements change regularly, so tools must keep up.

Most small organizations underestimate how frequently these elements must be reviewed, upgraded, and revalidated.

Hidden Costs That Don’t Appear in Budgets

Even when internal resource costs are estimated accurately, organizations often miss the following:

• Time burden of system validation and upgrades (often triggered by regulation or guidance refinements).

• Demand for year-round documentation maintenance, not just during submission crunch.

• Risk of knowledge loss when internal staff turnover (especially critical for rare submission cycles).

• Internal IT and security impact when tools require audit access, documentation storage, or restricted permissions.

• Training and performance management, which become critically important factors when publishing volumes increase.
  

When Publishing Controls Falter, Small Problems Become Regulatory Problems

When the underlying infrastructure isn’t fully in place, issues rarely appear as dramatic failures. They tend to surface quietly, then accelerate. A missing metadata field becomes a chain of inconsistent files. A single version mix-up leads to conflicting content across modules. A reviewer’s unlogged change creates a traceability question that no one can answer cleanly.

The real challenge is timing. These issues usually show up when the clock is almost out during pre-QC, while assembling final sequences, or after a regulator spots an inconsistency. What could have been an early correction becomes an all-hands scramble.

And once confidence erodes, the impact cascades. Review cycles stretch. Authors lose trust in the process. Leadership becomes anxious about hitting key milestones. Every delay has a financial consequence, but the reputational strain inside the organization can be just as damaging.

This is why the cost of weak controls is rarely described as, “We had to fix a few files.” It’s often more likely, “We missed a critical milestone because our processes weren’t built to handle the complexity.”

The Real Cost Often Isn’t Rework; It’s Delay

Even seemingly minor publishing setbacks can lead to missed submission deadlines. For companies targeting critical development milestones, commercial launch timelines, or funding inflection points, delays have significant downstream consequences.

Industry benchmark data suggests that clinical-stage companies can incur hundreds of thousands of dollars per day in delay costs when regulatory timelines slip, even before considering investor confidence and competitive exposure.

The Compounding Risk Factor

Attempting to maintain a publishing capability without a robust infrastructure can create vulnerabilities that go unnoticed until late-stage QC or during a regulatory audit. Small companies often believe that lower submission volume means lower compliance risk. In practice, regulators expect traceability, regardless of team size. A small submission from a company with two internal staff still carries the same inspection expectations as one from an organization with a dedicated publishing department.

Why Outsourcing Can Be More Cost-Effective, Even for Small Teams

Outsourcing regulatory publishing enables small teams to leverage a partner with resource capacity who:

• Already maintains validated systems and compliant workflows.

• Has established governance, audit trail processes, and documentation practices.

• Is built for operational surge during major submission events without compromising quality.

• Provides continuity even when internal priorities shift.

• Offers scalable access to experienced specialists without requiring full-time employment.
  

The real ROI of outsourcing comes from consistent, high-quality submission support across the submission lifecycle, reduced risk, and avoidance of the infrastructure investment required for regulatory publishing.

A Practical Guiding Question

Before committing to building internal capabilities, leaders should honestly evaluate:

Are we better served by investing scarce internal bandwidth in building and maintaining a publishing infrastructure, or by directing that energy toward science, strategy, and speed to milestones?

For many small and growing organizations, the answer becomes clear once they understand what’s beneath the surface of publishing operations. That’s where a strategic publishing partner becomes invaluable.

If you’d rather focus your internal resources on science and strategy, let WAYS handle regulatory operations. Our mature infrastructure, experienced specialists, and client-focused approach are built around submission success.

Contact the WAYS team