Independent, senior-level advice for pharmaceutical companies, biotechs and CROs that need sound medical judgement and defensible compliance. We also help you adopt AI in drug safety and medical information safely, with qualified physicians accountable for every decision.
Medical judgement and direct senior involvement across your safety and medical information functions.
Practical, risk-aware modernisation of PV and MI, with qualified people accountable for every decision.
Independent advice for pharma companies and CROs on risk, partners and growth.
What you hire is experience, delivered directly.
Every engagement is led and delivered by senior physicians. Your work is not handed to a junior team after the pitch.
We have no operations to sell and no technology to resell. Our recommendations follow your interests and the evidence.
Where AI and automation are used, medical accountability stays with qualified people. We design for that deliberately.
Global and regional organisations strengthening PV and MI governance, modernising operating models and overseeing outsourced partners.
Emerging companies building a first compliant PV and MI capability, ready for approval and launch, without carrying unnecessary overhead.
CROs and service providers refining their PV and MI offering, differentiating with medical leadership and growing through partnership or acquisition.
Our consulting approach is shaped by the perspective of a physician and pharmacologist with experience spanning:
Having founded and led a pharmacovigilance and medical information business through a successful acquisition by ProPharma Group, we understand:
Led by an experienced CEO and supported by a team of global consultants across the UK, US, EU and APAC, including dedicated QPPV and EU QPPV expertise, bringing together extensive international regulatory and pharmacovigilance experience.
Medical training and clinical practice underpin every safety and medical judgement we offer.
Former Drug Safety Physician and Global Safety Surveillance & Risk Management Consultant at Mylan UK. 15 years of regulatory audits and inspection experience globally.
Built iSAFETY global PV and MI operations working with 50+ global pharma and biotech companies. Led it through its successful acquisition by ProPharma Group, with first-hand experience of growth, diligence and integration.
Whether you are strengthening your PV or MI framework, evaluating AI opportunities or navigating a strategic business decision, let’s start with a focused conversation.
Tell us what your organisation is working through. We’ll discuss the context and determine whether our consulting expertise is the right fit.
Request a consultation ↗Confidential discussion · Flexible advisory engagements · Global perspective
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