Fixed-scope projects, ongoing retainers, or fractional regulatory support — structured around your stage, not ours.
We define your regulatory pathway early — classification, applicable regulations and evidence expectations — so you build the right documentation once. Then we write and manage the submissions.
We work across EU MDR and IVDR technical documentation, FDA 510(k), De Novo and PMA submissions, and the evolving UK MHRA framework, including notified body selection and question rounds.
Startups get a right-sized ISO 13485 system that won't collapse under its own paperwork. Scale-ups get remediation and audit-readiness. Everyone gets a system mapped to what regulators now inspect against — including FDA's QMSR, in force since February 2026.
Drug-device combination products fail when the two regulatory worlds don't talk to each other. We bridge them: device design controls that satisfy pharma reviewers, and drug-delivery evidence that satisfies device auditors.
From pre-filled syringes and autoinjectors to inhalers and on-body delivery systems — for pharma companies adding a device, and device companies entering combination territory.
Manufacturers outside the EU — including every UK manufacturer since Brexit — must appoint an EU Authorised Representative (also known as an "EC REP") before placing devices on the EU market. We act as your AR under MDR/IVDR Article 11, operating from Sweden with a documented quality system, a qualified PRRC and Eudamed registration.
Unlike letterbox providers, we verify your technical documentation before we put our name on your label — and because we're consultants first, the gaps we find are gaps we can help you close.
That's normal — most clients arrive with a deadline, not a service name. Tell us where you're stuck and we'll tell you honestly what it takes.
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