Adetona

WORK HISTORY

EDUCATION

SKILLS

ABOUT ADETONA

Bridging Clinical Governance and AI Driven Innovation in Health & Life SciencesI am a senior regulatory affairs and clinical governance leader with over 25 years’ experience spanning global markets (UK, EU, Africa, Switzerland). My unique strength lies in blending deep regulatory science, mental health clinical experience, and a forward-looking lens on AI, digital health, and Software as a Medical Device (SaMD).Core expertise includes:• Regulatory strategy for AI/ML-enabled SaMD and orphan drugs• Clinical governance frameworks in healthcare innovation• Mental health assessments & digital care implementation• Medical writing, dossier development, training, and AI-readiness auditsThroughout my career, I’ve advised biotech, pharma, digital health and consumer healthcare companies on regulatory pathways for:• Orphan/rare disease therapies• AI-based diagnostics and clinical decision tools• Controlled drug supply chains• Nutraceuticals and borderline productsOrphan Now leverages regulatory expertise to address the unique challenges of paediatric rare and orphan diseases. As a Partner with extensive experience in global regulatory affairs, I focus on strategic planning, regulatory compliance, and UK/EU member states\' commercial operations. My contributions emphasize developing streamlined pathways for expedited approvals and ensuring alignment with international guidelines. With over two decades of experience, including recent leadership at Sciensus, I bring a proven ability to integrate regulatory strategies with business goals. My mission is to empower teams and innovators in the healthcare space to navigate complex regulatory landscapes effectively. How I can help:• AI-readiness regulatory audits (MHRA, EMA, FDA)• Regulatory strategy for SaMD / digital therapeutics• Clinical governance systems for AI-enabled care services• Mental health assessment frameworks and policy integrationI also offer advisory services, webinars, and bespoke training for startups and teams navigating the complex interplay between technology, clinical care, and regulation. I\'m passionate about helping healthtech innovators and clinical service providers meet evolving regulatory requirements, particularly as AI transforms how care is delivered, measured, and governed. Let’s connect if you\'re building in this space, or looking to elevate regulatory strategy, compliance, or AI integration in healthcare. I’m eager to collaborate with healthtech startups, VCs, and organisations navigating the exciting intersection of AI, healthcare innovation, and regulation.