Growth & Regulatory Consultancy for Life Science
& Tech Ventures
Expert regulatory, compliance and operational guidance to get your product to market without the guesswork
You have a product or technology with the potential to improve lives. What you may not have is a clear, realistic path to market.
Regulatory pathways, compliance and quality management are not just box-ticking exercises - they determine whether your product ever reaches the people you designed it for.
We provide the strategic clarity and hands-on support to make that journey as efficient, compliant and cost-effective as possible. You’ll work with a core regulatory and quality lead, supported by a wider team of specialist associates so the whole route to market is aligned, from commercial strategy and organisational leadership to strategic marketing and website design.
WHY YOU NEED THIS
You understand your product deeply, but the regulatory pathway is unclear, and you fear the assumptions you are working from may not be accurate
You need a realistic picture of the timelines, documentation and management requirements before you go further
You want senior specialist expertise without the cost or commitment of a full-time hire at this stage
You want support tailored precisely to your product, your risk class and where you are right now
WHAT WE DELIVER
We clarify your regulatory and quality strategy, map the required activities and documentation, and design a realistic roadmap to market. We then support implementation through a consulting team working in flexible, project‑based arrangements that pause and restart as your needs evolve - including regulatory and quality specialists, commercial strategy advisors, and strategic marketing and website design partners.
We also help you design and scale compliant operations, developing robust quality and compliance management as you grow from early-stage to fully scaled.
“Sarah provided us with invaluable consulting support in understanding and assessing MDR requirements for our web application. She explained complex regulations in a clear way and guided us through the process with professionalism and efficiency. Her expertise gave us confidence that we are on the right track with compliance, and we will be a returning client for further consulting and assessments.”
— Dr Siamak Dadbin, CEO at Medicinskoptik, Software as a Medical Device Company“She has a deep understanding of what it takes to approve, launch and generate revenues combined with a strong commercial drive and proactive approach.”
— Dr Ben Wicks, CEO at Ucertainty, In Vitro Diagnostics Start up
OUR CONSULTANTS
Sarah Mardle, PhD
Leadership & Operational Strategy in Regulated EnvironmentsSarah guides organisations through regulatory and operational complexity to build a clear, efficient path to market. Drawing on senior experience across startups, scaleups and global organisations, she brings the clarity, judgement and practical insight leaders need to make informed decisions in high‑stakes, highly regulated settings.
Philippa Burns, PhD
Philippa helps life sciences and health tech teams turn complex ideas into robust, launch‑ready products. With experience across industry and academia, she supports organisations developing and scaling innovative diagnostics and research‑use tools from early concept through to transfer and launch. Blending scientific depth with practical execution, she strengthens design control, development processes and risk management, enabling high‑quality, compliant product development that maintains momentum.
Life Sciences Product DevelopmentOperational StrategyLaura Sloman
Laura brings deep operational leadership experience to organisations scaling in regulated sectors, helping them build the structures and capabilities needed for sustainable growth. Drawing on her experience in senior healthtech positions, she applies agile, lean principles to strengthen governance, improve processes and build team capability — enabling organisations to grow with clarity, pace and care for their people.
Brigitte Scott, PhD
Medical Writing and Scientific CommunicationBrigitte is an experienced medical writer and editor who delivers high‑quality scientific communication in many therapeutic areas across pharmaceutical, biotechnology and healthcare sectors. From clinical and regulatory documents to publications, training resources and conference outputs, she writes, reviews and edits materials, bringing clarity, accuracy and specialist expertise.
Nicky Dibben
Commercialisation and Strategic MarketingNicky helps deeptech ventures turn complex innovation into clear commercial strategy. She supports spinouts, startups and established companies to identify the right markets, shape compelling value propositions and build scalable routes to market. She also contributes to Alma’s entrepreneurship programmes through lectures and mentoring.
Natalie Weir
Human-centred Design and Usability EngineeringNatalie brings deep expertise in user insight and usability practice across the medical product development lifecycle. She works from early development through to final validation, ensuring products meet regulatory expectations and are designed to be safe and effective. Her agile, tailored support helps teams de‑risk early and create products people can use, choose to use, and that deliver meaningful clinical benefit.
Data Visualisation and Scientific CommunicationRita Giordano, PhD
Rita specialises in translating complex scientific and healthcare data into easy to understand and accessible to enable better understanding and decision‑making. She designs user‑centred charts, dashboards, and investor‑ready data stories. She runs workshops on data communication for entrepreneurs, helping teams present their data with accuracy, clarity and impact.
Margaux Grasso
Strategic Marketing Margaux helps growing science and technology teams bring more clarity, structure, and direction to their marketing. Combining strategic marketing with a collaborative approach, she helps teams build and implement strategies that are not only well defined, but actually executed across the business.
Ellie Senior
Strategic CommunicationsEllie specialises in clear, impactful storytelling for life science and tech ventures. Her clarity-driven work has supported start-ups and scale-ups across the Cambridge ecosystem, helping organisations to articulate complex ideas with confidence across high stakes audiences.
Krishna Solanki
Website Design and BrandingUsing brand strategy, visual identity and high-performing website design, Krishna helps life science and technology organisations turn complex ideas into clear, compelling brands that connect with investors and clients.
FREQUENTLY ASKED QUESTIONS
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Accelerators offer valuable general guidance, but they cannot provide the tailored, product-specific regulatory strategy your venture needs. We read the regulations, map your exact pathway and support hands-on implementation. This work is at a level that free programmes cannot deliver.
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Earlier than you think. Early clarity prevents costly rework, unrealistic assumptions and delays. Whether you’re shaping your concept or preparing for submission, we help you make informed decisions from the start.
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Absolutely. Many founders come to us unsure of their classification, documentation needs or regulatory obligations. Uncertainty is normal, and resolving it early saves time, money and risk later.
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Often, no. Our model provides senior expertise on a flexible, project basis. You get the capability you need without the cost or commitment of a full-time hire before you’re ready.
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We do. Once your pathway is defined, we can help create documentation, set up systems, prepare for audits and guide interactions with regulators through our specialist associates.