Scaling Without Becoming “Big Pharma”
How Small Biotechs Can Grow Commercially and Stay Agile Without Compromising Compliance
For biotech companies, the transition from R&D to commercialisation represents a defining milestone.
Scientific innovation makes way for market visibility. Interactions widen, from internal researchers and academic collaborators as an R&D organisation, to healthcare professionals (HCPs), healthcare organisations (HCOs), partners, patients, regulators and payers. Expectations shift, not only about products, but about governance, behaviour, and control.
One common misconception among transitioning biotechs is that compliance “switches on” at launch.
In reality, healthcare compliance obligations emerge progressively and often earlier than expected, particularly once external engagement increases. Activities such as advisory boards, investigator meetings, disease awareness, early access programmes, sponsorships and partnerships can all trigger code and regulatory expectations well before the first commercial sale, and even prior to NDA or marketing authorisation submission.
So how do you ensure compliance without compromising on the agility and innovative culture that got you to where you are today?
The “Big Pharma” Trap
As biotechs prepare for late‑stage development, partnering or launch, it is common to see over-compensation when it comes to compliance. For example:
- Complex SOP libraries, often copied from large pharmaceutical companies
- Multiple layers of approvals implemented “to minimise the risk”
- Compliance frameworks designed for global commercial operations rather than tailored towards early launch teams
- Controls introduced to satisfy internal perceptions of risk, not actual regulatory and compliance risk
Organisations that take this approach often come to see compliance as a blocker rather than an enabler. Bureaucracy breeds frustration and value is obscured. Teams begin to circumvent heavy processes to move things forward. Over time, these workarounds become the normal way of working.
Regulators do not expect small biotechs to mirror multinational pharmaceutical companies. However, they are operating under the same regulatory framework and are expected to demonstrate evidence of proportionate control, accountability, and risk awareness, aligned to their size, activities, and stage of development.
“Right-Sized Compliance Frameworks
Compliance does not need to be complex to be effective. What matters is whether it:
- Manages real risks, not theoretical ones
- Is understood by the teams expected to apply it
- Is designed to scale as the organisation grows
A proportionate compliance framework focuses on what must be controlled, by whom, and why. It is not measured by the number of policies and procedures.
For a small or mid-stage biotech, this typically means starting with a core set of controls, such as:
- Clear principles governing HCP/HCO engagement
- Who makes decisions about, and takes accountability, for medical, commercial and external interactions
- Practical processes for approvals, contracting and transfer of values to HCPs, including Fair Market Value assessments
- Clear escalation routes for any issues, potential breaches, and grey areas
- Pragmatic, role-based training compared to high level or “read and understand” exercises
Small or mid-stage biotechs should prioritise the controls linked to the most material risks. These risks can change as the organisation grows and exposure increases, so they should be revisited accordingly.
Maintaining Both Agility and Compliance
A common fear among leadership teams is that introducing governance and compliance requirements will slow innovation. In practice, the opposite is often true.
If processes are well-designed, they can reduce uncertainty, speed up decision-making and give teams clarity about what is, and is not, permissible. When people understand the guardrails, they move faster rather than slower.
Agility is best preserved when:
- Processes are decision-focused, not document-heavy
- Approvals are aligned to the level of risk; not all decisions need to be escalated
- Exceptions are anticipated and managed, rather than prohibited outright (which risks driving workarounds)
- Teams are empowered to exercise judgement within a clear framework
This is important in biotech environments. Roles are fluid and changing; a small team means individuals often wear multiple hats. Compliance frameworks must accommodate what happens in practice, whilst remaining robust and defensible.
Compliance as a Business Enabler
Compliance is often under-resourced and introduced too late when ways of working are already established. Retro-fitting compliance is inherently difficult. Activities cannot be “re‑approved” retrospectively in a credible manner; they can only be explained. Organisations have to explain the past, manage the present, and build the future, all at the same time, a significant leadership challenge.
A more effective approach is to start early and embed compliance thinking into existing decision-making structures, for example:
- Integrating compliance risk considerations into project governance and portfolio discussions
- Aligning with medical, regulatory and commercial decision points rather than duplicating them
- Framing compliance questions in business terms: impact, risk, mitigation and consequence
Compliance should not be a separate layer, bolted on. It should become part of how the organisation operates.
Scaling Over Time
The goal is not to remain small forever. Successful biotechs plan for growth but build in the ability to scale over time.
A scalable compliance framework typically:
- Establishes the basics, focused on the core risks
- Uses modular policies that can be expanded rather than replaced
- Avoids embedding unnecessary global complexity before it is needed
- Anticipates future expectations such as transparency, audit, and reporting
- Creates data and documentation that is robust enough to withstand scrutiny from partners, regulators or acquirers
This approach reassures investors and partners that the organisation is credible from a commercial perspective, without undermining its entrepreneurial and agile mindset.
Transitioning from R&D to commercial is less about becoming big pharma, and more about becoming ready. Ready for scrutiny. Ready for growth. Ready for accountability.
A Pragmatic Maturity-Led Approach
At GRC Catalyst, we support biotech organisations to design governance, risk and compliance frameworks that are:
- Proportionate to organisational size and activity
- Aligned to current and emerging regulatory expectations
- Practical for small teams operating under pressure
- Flexible enough to evolve through partnering, launch and scale up
Rather than asking “What does big pharma do?”, we start with the question “What level of control is necessary, defensible and value adding at this stage of the journey?”
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.
