How we can help
With deep expertise across regulatory strategy, policy and advocacy, organisational design, and leadership development, we provide practical support tailored to your needs. Whether you’re navigating complex legislation, building robust compliance systems, or strengthening your regulatory team, we work alongside you to achieve results that drive your business forward
Regulatory Strategy
We help you move beyond compliance to create true competitive advantage. Our deep understanding of global regulatory landscapes means we can develop strategies that anticipate change, rather than simply react to it.
Whether you’re looking to bring a new product to market, maintain the compliance of your existing portfolio, or prepare your business for upcoming legislative shifts, we guide you through every step with pragmatic, commercially focused advice.
We support you in:
Developing clear, actionable regulatory strategies tailored to your products and markets
Managing regulatory risks to maintain market confidence and operational resilience
Implementing strategic changes through programme management support that ensures smooth integration across your organisation
Our approach is collaborative and solution focused. We can work as an extension of your team or on a project by project basis to build strategies that protect your business today while enabling its growth tomorrow.
Intelligence, Policy and Advocacy
We monitor evolving legislation, regulatory frameworks, and policy trends to keep your business ahead of change. Our deep expertise allows us to identify emerging issues early and assess how proposed regulations might impact your products, operations, and strategic goals.
We help you build robust policy positions that are evidence-based, commercially aligned, and clearly articulated to resonate with regulators and stakeholders. Our support extends to developing targeted advocacy plans that identify the right opportunities and channels to influence outcomes effectively.
From drafting consultation responses to engaging directly with regulatory bodies and industry associations, we can ensure your organisation’s voice is heard and your interests are represented with credibility and clarity.
In addition, we can provide programme management support to implement resulting changes smoothly across your organisation. Whether adapting internal processes, updating compliance systems, or communicating legislative impacts to wider teams, we work alongside you to ensure changes are embedded efficiently, effectively and on time.
Our approach combines strategic foresight, strong stakeholder engagement, and pragmatic implementation to help you navigate complex regulatory changes with confidence and we can be as involved as much or as little as works for your business.
Organisational systems and structures
We design regulatory and compliance functions that work with your business, not against it. Whether you’re scaling up, entering new markets, or reshaping your organisation, we build structures and systems that are robust, agile, and commercially aligned.
Our approach begins by understanding your strategic goals and operational realities. We assess your current organisational design, operating models, and ways of working to identify what’s working well and where improvements will deliver the greatest impact.
From designing effective organisational structures and clear role accountabilities to developing integrated operating models that connect regulatory, quality, and commercial functions seamlessly, we ensure your teams can deliver efficiently and confidently.
We also support the development, optimisation, and simplification of Quality Management Systems (QMS), compliance processes, and governance frameworks to reduce complexity while strengthening compliance. Our focus is always on creating practical, simple, and effective approaches that work in real life, not just on paper.
Whether you need to establish scalable systems for growth, integrate regulatory functions post-acquisition, or transform outdated processes to meet evolving business needs, we provide pragmatic, tailored solutions that build long-term capability and resilience.
Leadership and mentoring
Strong regulatory functions begin with strong people. We mentor and develop regulatory professionals to think strategically, influence effectively, and grow alongside your organisation’s needs.
Our support focuses on building both technical and commercial capability, while developing the critical soft skills needed to become true business partners. We help your regulatory teams understand not just the what and how of compliance and your business, but the why enabling them to make confident decisions that balance regulatory requirements with commercial realities.
From tailored training programmes that strengthen technical expertise, to team-building workshops that enhance collaboration and cross-functional working, we create development solutions that are practical, engaging, and impactful. We also provide one-to-one mentoring and coaching to support individual leaders in navigating challenges, building confidence, and broadening their strategic thinking.
Whether you’re looking to build capability in a growing team, develop succession plans for key roles, or support high-potential individuals to step into leadership positions, we help you build the next generation of regulatory leaders who can drive your business forward with confidence.
Products and classifications
With extensive experience across a broad spectrum of product types including medicines, medical devices, cosmetics, general consumer products, biocides, pesticides, disinfectants, food supplements, and electrical goods, we bring a comprehensive understanding of regulatory complexities unique to each category with a global perspective.
Navigating product classification can be challenging, as it depends on factors such as mode of action, intended claims, available data, target markets, and project timelines. We guide you through this intricate “classification dance,” helping you identify the most efficient and compliant regulatory pathway tailored to your specific product and business objectives.
Our approach is adaptable and commercially focused, supporting organisations of all sizes, from agile startups to established multinational corporations. By integrating flexible regulatory strategies with pragmatic execution, we enable you to accelerate time to market while managing risk, ultimately driving sustainable commercial success.