Right-Sized Compliance: Building Process Maturity
In early-stage biotech companies, informality works well. Small teams, fast decisions, and shared context allow organisations to move quickly without building a heavy infrastructure. However, as the business grows, adding new functions, engaging externally, and preparing for launch, that same informality can create risks in an evolving organisation.
You don’t need to replace agility with bureaucracy. The aim is to introduce proportionate, scalable processes and policies that reflect your organisation’s size, maturity, and evolving risk profile.
In other words: right-sized compliance.
What is right-sized compliance?
Right-sized compliance means designing policies and processes that are fit for purpose today, but capable of evolving as the organisation grows.
This avoids two common pitfalls:
- Too little structure – informal processes, informal decisions that are not documented, and unclear accountabilities.
- Too much structure, too soon – importing large-company frameworks which are over-engineered for the current size of the organisation, creating unnecessary complexity and delays.
Right-sized compliance sits in the middle. It recognises that policies and processes should be based on:
- The current phase of your organisation.
- The nature of the activities being undertaken.
- The risks your business is now exposed to.
- The likely future expectations as your organisation approaches commercialisation.
Right-sized compliance is about having the right controls, at the right level of maturity, at the right time.
Why process maturity matters at this stage
Process maturity refers to how clearly, consistently, and reliably an organisation defines and operates its key activities as it grows.
Process maturity becomes critical because it:
- Drives consistency – without clear processes, similar decisions are handled differently across teams, leading to inefficiency and gaps in control.
- Reduces dependency on individuals – when processes exist only in people’s heads or rely on one person, scaling becomes fragile. Documentation enables continuity and onboarding.
- Clarifies how functions work together – cross-functional activity increases, but roles and responsibilities are often unclear. Processes define touchpoints and accountability.
- Supports defensible decision-making – as scrutiny increases, organisations need to demonstrate not just outcomes, but how decisions were made.
What proportionate and scalable processes look like
“Proportionate” and “scalable” are easy words to use and surprisingly hard to apply well.
In practice, effective processes at this stage share a few characteristics:
- Aligned to current activity and risk – not a theoretical future state. A 100-page SOP with six approvals may not be appropriate for a biotech with a lean team and a small number of annual activities. The process should reflect the actual volume, complexity, and risk of the activity.
- Clear but pragmatic – enough guidance to drive behaviour, without over-specification. A policy should not be so high-level that people still do not know what to do. Equally, it should not attempt to cover every possible scenario in excessive detail. Good documents provide principles, roles, decision criteria, and practical guidance.
- Usable by the business -designed for real-world application. If a process is too complicated to follow in real life, people will route around it. A scalable process is one that can be understood, applied, and sustained by the teams expected to use it.
- Built to evolve – they can be strengthened without being dismantled and re-built. They provide a workable baseline now, but can be expanded later with additional guidance, approval steps, templates, training, or monitoring as the risk profile increases.
How to build for the future, without overbuilding
One of the biggest mistakes organisations make is assuming maturity should be driven by aspiration rather than exposure. The better question is not “What would a large pharma company have?” but “What risks do we actually need to manage now – and what will emerge next?”
Effective organisations take a staged, deliberate approach, starting with core enablers:
- Document governance.
- Approval principles.
- Roles and responsibilities.
- Records management.
- Issue escalation.
But what does this mean in practice? At GRC Catalyst, we’ve found this works:
- Use modular policies – Develop concise core standards, then expand through guidance, templates, and training.
- Design risk-based pathways – Differentiate between low and high-risk activities from the outset.
- Clarify ownership early – Many process failures are ownership failures. Define accountability clearly.
- Leverage templates – Simple tools (forms, checklists, logs) drive consistency without heavy frameworks.
- Expect iteration – Processes should evolve as the organisation grows. They should not aim for perfection on day one.
Final thoughts
For biotechs transitioning to Commercial, process maturity is not about building “big company” infrastructure.
It is about creating enough structure to support consistent, defensible, scalable operations, while preserving the agility that drives innovation.
That is the foundation of right-sized compliance.
Right-sized compliance enables organisations to grow with confidence without the need to rebuild from scratch.
How can GRC Catalyst help?
GRC Catalyst supports organisations in implementing right-sized compliance by translating complex regulatory expectations into practical, proportionate, and scalable frameworks aligned to each stage of growth.
We work closely with leadership teams to identify the key risks that matter now, design clear and usable policies and processes, and establish foundational governance that can evolve over time.
The focus is on building structures that support scaling businesses without adding complexity.
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.
