Eunomia Pharma Services
All resources

Eunomia perspective · 2026-03-30 · Compliance Programmes, Audits & Training, EFPIA Code Compliance

Entering Phase III? Compliance Expectations Already Have

Published by Eunomia Pharma Services · Updated

What compliance does a biotech need before Phase III and launch?

At Phase III, regulators, partners and investors start assuming a functioning compliance system. The foundations are proportionate policies aligned to real activities, a defensible FMV methodology, structured third-party risk assessment, transparency tracking across markets, governance for HCP and patient organisation engagement, and practical escalation routes between medical and promotional activity.

Foundations to put in place

  1. Document FMV justification for advisory boards and consultancy.
  2. Run due diligence on distributors, especially in higher-risk jurisdictions.
  3. Track transfers of value consistently across affiliates and vendors.
  4. Assign clear ownership for local requirements, such as French transparency obligations.

The practical steps above are Eunomia’s operational guidance. See the source notes below for the scope of the external references.

Many biotech companies treat healthcare compliance as something to “scale later.” In reality, Phase III is the moment when compliance shifts from optional structure to operational necessity. Ignore that transition and risk begins accumulating faster than most leadership teams expect.

As organisations approach registration and launch readiness, their stakeholder footprint expands rapidly across investigators, healthcare professionals (HCPs), patient organisations, distributors, regulators, and payers. At the same time, expectations from frameworks such as the EFPIA Code and national transparency regimes become unavoidable.

This is the stage where regulators and partners start assuming you already have a functioning compliance system.

Where Phase III Companies Commonly Get Caught Out

Compliance gaps at this stage are rarely dramatic. They are operational and cumulative.
Typical examples include:
  • advisory boards organised without documented Fair Market Value (FMV) justification
  • investigator meetings drifting into promotional positioning before approval
  • distributor onboarding without structured due diligence in higher-risk jurisdictions
  • early market-shaping conversations with payers lacking internal governance oversight
  • transfers of value tracked inconsistently across affiliates or vendors
  • local country requirements such as France transparency pre-notification missed because responsibility is unclear
Individually, these issues seem manageable. Together, they create audit exposure, delay partnerships, and complicate launch readiness.
Increasingly, investors and licensing partners also expect compliance maturity as part of diligence, not after commercialisation but before.

Compliance Enables Launch Readiness. It Does Not Slow It

Strong compliance frameworks at Phase III do not mean building “big pharma infrastructure.” They mean building the right foundations early:

  • proportionate policies aligned to real activities
  • a defensible FMV methodology
  • structured third-party risk assessment
  • transparency tracking across markets
  • engagement governance for HCPs and patient organisations
  • practical escalation pathways for medical versus promotional boundaries

Done properly, these systems accelerate decision-making rather than restrict it.

They also reduce friction when entering Europe, where country-level expectations differ significantly even within harmonised regulatory environments.

The Hidden Risk: Commercial Activity Starts Earlier Than You Think

Strong compliance frameworks at Phase III do not mean building “big pharma infrastructure.” They mean building the right foundations early:

Examples include:

  • payer evidence discussions during market access preparation
  • disease awareness initiatives
  • advisory boards informing positioning strategy
  • early distributor negotiations outside core territories

These are legitimate activities, but they require structure.

Without documentation, oversight, and alignment with local requirements, they can quickly fall outside defensible compliance boundaries.

Scalable Compliance Is Achievable Without Heavy Systems

Phase III organisations rarely need enterprise compliance platforms immediately. What they need is visibility, governance clarity, and consistency.

Lean frameworks built on structured workflows, often within existing environments like Microsoft 365, can support:

  • engagement approvals
  • materials lifecycle tracking
  • transparency data capture
  • policy accessibility
  • role-based training delivery

This creates audit-ready discipline without unnecessary complexity.

A Strategic Opportunity, Not Just a Risk Mitigation Exercise

Compliance maturity signals credibility to regulators, partners, investors, and future affiliates. It strengthens licensing discussions, supports European expansion, and reduces delays during launch preparation.

Most importantly, it allows leadership teams to scale engagement confidently rather than cautiously.

Phase III is not too early to invest in compliance structure. It is often just before it becomes urgent.

Sources and scope

External sources accessed 29 September 2026. Check the applicable country rules and current source text for a specific engagement.

Put this into practice