REGULATORY AFFAIRS · MANAGEMENT · TRAININGWhere compliance becomes competitive advantage.
Regulatory affairs isn’t an overhead. It’s your key to market entry.
A new procedure, a submission, succinct training, or a whole staffing model - we’ve got it covered.
We can offer targeted solutions, additional resource, ad-hoc advice or full strategic solutions across three complementary segments.
We solve problems in the medical devices regulatory space - big and small.
Early stage
Applicable legislation, classification, route to market, clinical evidence strategy and a sequenced roadmap with estimated timelines, costs and a risk register, for your target markets.
Find out moreWe are building a programme of online and in-person training, with various entry points catering to different experiences and backgrounds. Train yourself and your team for the regulatory journey.
Find out moreAn experienced regulatory affairs director for a set number of days a month: strategy, board reporting, notified body engagement and building your RA function until you hire full time.
Find out morePre-market
Writing, review and correction of technical documentation, from labelling and IFU to design control, risk management and clinical evaluation, plus answers to notified body questions.
Find out moreFor a start-up or spin-out, writing your first clinical evaluation is a battle of language - translating what you know from your clinical experience, to regulatory clinical justifications.
Find out moreWe are building a programme of online and in-person training, with various entry points catering to different experiences and backgrounds. Train yourself and your team for audits and regulatory submissions.
Find out moreMock QMS, technical documentation, unannounced and supplier audits against ISO 13485 and EU or UK MDR, with an audit report, gap closure recommendations and audit skills coaching.
Find out moreOur fixed price gap assessment reports a likely assessment outcome, readiness scores across eleven technical areas, and gaps ranked by commercial impact, so you can close them before submission.
Find out morePost-market
Research into target markets, a go-to-market plan covering legislation, assessment routes and registration, or management of the full application with in-country representatives.
Find out moreA leadership-level review of regulatory risk across your products and organisation, prioritised by commercial impact, with recommended actions.
Find out moreA review of team structure, capability and workload, with a role framework that relieves senior bottlenecks and reduces reliance on contractors.
Find out moreDefined career paths with job descriptions, expected skills for each role and training matrices, giving staff a route to progress and you clear promotion criteria.
Find out moreOngoing development for quality and regulatory staff, with records and verifiable micro-credentials you can show as evidence at audit.
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