The “We’ll fix it later” Trap
For biotech companies transitioning from R&D to Commercial, “we’ll fix compliance later” is often a coping mechanism rather than a conscious decision.
Resources are stretched. The science is demanding. Investors are watching timelines. Recruitment is high on the agenda. Against that backdrop, healthcare compliance can feel like something that can wait… until after launch, after the next financing round, or after the organisation feels more “commercial”.
The problem is that when “later” arrives, it comes with significantly higher cost, risk, and disruption.
At GRC Catalyst, we often see this mindset in biotech organisations approaching commercialisation of their first product. This article explores why companies fall into this trap, the risks it creates, and what a more sustainable operating model looks like.
Why biotech organisations fall into the “we’ll fix it later” trap
- Competing priorities during rapid change
As organisations move toward late‑stage development or launch readiness, everything feels urgent:
- Building medical and commercial capabilities
- Engaging KOLs more frequently
- Preparing launch materials
- Strengthening partnerships and investor engagement
In this environment, compliance initiatives are deprioritised. There’s a lack of clarity over what needs to be in place and when so compliance is deferred until later.
- Misconceptions about when healthcare compliance “starts”
A very common, and costly, misconception is that healthcare compliance only “switches on” at product launch.
However, Industry codes and regulatory expectations are triggered by activity, not by milestones such as NDA submission or marketing authorisation. External engagement such as advisory boards, scientific exchange, disease awareness, sponsorships, early access programmes and partnerships can all attract code scrutiny before commercialisation.
This is explicit in the EFPIA Code, which applies to interactions with healthcare professionals, organisations and patient groups regardless of whether a product is already marketed. This position is also reflected consistently across national and global codes.
This mismatch between internal self‑perception (“we’re still R&D”) and external expectations (“you are acting commercially”) is where many organisations begin accumulating unmanaged risk.
- Fear of “big pharma bureaucracy”
Another driver of delay is fear, particularly fear of over‑engineering:
- Large, complex SOP libraries copied from big pharma
- Lengthy approval chains that slow decisions
- Controls that feel disconnected from how small teams actually work
Leaders worry that introducing compliance too early will destroy agility and innovation. Ironically, this often leads to the opposite outcome: a late, panicked implementation of controls that is far more disruptive.
The risks created by a “fix it later” mindset
- Retrofitting almost always costs more
When compliance frameworks are bolted on after behaviours, systems, and ways of working are already embedded, organisations face significant re‑work:
- Activities that cannot be credibly retrospectively approved
- Incomplete or inconsistent documentation
- Systems that cannot support audit or transparency requirements
External research across regulated life sciences environments consistently shows that reactive compliance introduces higher cost, requires more remediation, and introduces greater audit exposure than planned, phased implementation.
- Inherited risk decisions become future liabilities
Risk decisions made in an early R&D context may have been reasonable at the time. The problem arises when those decisions are carried forward into the new commercial reality.
As organisations develop, risks that were acceptable yesterday become today’s compliance exposure, particularly in high‑profile areas such as promotional practices, medical‑commercial boundaries, and third‑party engagement.
- Investor, partner and regulator confidence is eroded
Increasingly, external stakeholders want to see that compliance is proportionate, embedded and defensible.
A patchwork or reactive compliance model can raise questions about:
- Governance maturity
- Leadership oversight
- The organisation’s ability to scale responsibly
These concerns often surface at precisely the moment the business needs confidence most, during partnering, investment or pre‑launch scrutiny.
A more sustainable alternative: compliance as a phased operating model
The answer is not to “do everything at once”. Effective organisations take a maturity‑led, risk‑based approach that allows compliance to evolve alongside the business.
- Focus first on the risks that matter most
Successful transitions start by identifying:
- Which activities trigger external code or regulatory exposure now
- Which risks could realistically derail commercialisation if unmanaged
- Where scrutiny is most likely to be focused in the next 12–18 months
This allows effort to be directed toward the highest‑impact risks, rather than spreading limited resources thinly across low‑value controls.
- Build compliance in phases, not as a “big bang”
Both external operating‑model research and real‑world biotech experience consistently show that phased implementation reduces risk and disruption compared with late‑stage rollouts.
A pragmatic approach typically includes:
- Establishing core governance and accountability early
- Implementing minimum viable policies and SOPs to support current activity
- Expanding scope and sophistication as exposure increases
This approach supports speed, clarity and control but without overwhelming small teams.
- Start with the basics, then mature deliberately
Early‑stage compliance does not require a full big‑pharma framework. It requires:
- Clear ownership and decision‑making
- Simple, understandable policies aligned to real activities
- Training that explains “why” requirements exist, not just “what” they are
As the organisation matures, controls can then be deepened, specialised and systematised.
- Design modular policies and SOPs
One of the most effective techniques we see is the use of modular documentation:
- Core global principles that remain stable
- Activity‑specific modules that can be added or refined over time
- Clear separation between mandatory controls and guidance
This avoids repeated rewrites and allows compliance to scale without constant reinvention.
Final thought: readiness is important, not perfection
Biotech organisations that navigate the R&D‑to‑Commercial transition successfully do not aim for zero risk or perfect compliance.
They aim to be ready:
- Ready for increased scrutiny
- Ready for faster decision‑making under clearer guardrails
- Ready to scale without losing control
“We’ll fix it later” is understandable, but it’s not a strategy. A phased, proportionate compliance operating model is.
How GRC Catalyst helps
GRC Catalyst helps biotech organisations build compliance at the right time, in the right way, supporting the transition from R&D to Commercial.
We help teams identify:
- Which current activities trigger regulatory and code expectations
- Where exposure already exists (often earlier than expected)
This means there are no surprises as you approach launch.
Disclosure
The concepts and ideas in this article are mine or have been referenced; I developed the body of the text and conducted the final editorial check. I used AI as a tool for research, to improve the flow and grammar of the article, and to check for factual inaccuracies.
