Your cause
Every regulatory challenge starts the same way: you know where you need to get to, but the path through is anything but clear. Whether the issue is AI governance, a complex registration dossier, or an organisation that hasn't kept pace with what the regulatory environment now demands — the real cost is usually the same. Time spent on the wrong things. Decisions made without the right information.
If any of the situations below sounds familiar, you're in the right place.
On knowledge and AI: Your team is running AI experiments — but no one has defined which tools are allowed, which data can be used, and who owns the output. Your regulatory intelligence lives in documents, inboxes, and experienced people's heads. When someone leaves, it leaves with them. You want to use AI to make your regulatory function faster and sharper. But you don't know how to do it in a way that is compliant, auditable, and actually useful.
On regulatory affairs: You are an SME in pharma, veterinary medicine, crop protection, or biocides that needs senior regulatory expertise without building a full in-house team. You are running a development programme, a lifecycle extension, or an authorisation procedure — and you need a partner who understands both the science and the regulatory system. Tracking what EMA, EFSA, ECHA, and national authorities are doing is consuming time your team does not have.
On your organisation: You are building or transforming a regulatory function — after a merger, a restructuring, or a strategic shift that changed what regulatory needs to deliver. Your RA team is capable but works in silos, with unclear ownership and processes that do not scale. You are looking for a mentor or coach who has actually been inside the industry, not just studied it.
Here is where I come in.
I work across three connected practice areas. Most clients start in one and find value in another.
Knowledge Management — AI & RAG
For organisations that want to use AI in a governed, data-sovereign, and compliant way, without sending proprietary regulatory content to public cloud systems.
I design and implement on-premise AI server solutions and RAG architectures (RAG: Retrieval-Augmented Generation — AI that answers from your own verified documents, not from guesswork) built on your regulatory document library. I train your teams to use them effectively and build the governance framework that makes the output compliant and auditable.
The result: your senior regulatory expertise gets multiplied, not replaced.
Services: On-premise AI server · RAG implementation · RAG user training
Regulatory Affairs
For SMEs and R&D organisations in pharmaceutical, veterinary, crop protection, and biocide sectors that need senior regulatory expertise. On a project, interim, or advisory basis.
I write and review regulatory dossiers, manage authorisation procedures and lifecycle activities, and track regulatory intelligence across the authorities that matter to your product. I work across the full regulatory spectrum: EMA, EFSA, ECHA, and national competent authorities.
The result: regulatory work done right, without the overhead of a full in-house team.
Services: Dossier writing · Lifecycle management · Approval procedures · Regulatory intelligence — Pharma · Veterinary · Crop Protection · Biocides
Organisational Development
For leaders who know that regulatory capability is a strategic asset, and want to build it deliberately.
I design and deliver coaching, mentoring, and training programmes for regulatory and R&D professionals. I help organisations map, redesign, and improve regulatory processes. And I develop personal development plans and team curricula that build tacit knowledge — not just procedural compliance.
The result: a regulatory function that learns, adapts, and leads — not one that merely keeps up.
Services: RA coaching & mentoring · AI strategy workshops · AI user training · Business Kickstart Workshops
