Services
Specialist pharmaceutical consultancy across the full regulatory and development lifecycle
Senior independent expertise — applied with precision, delivered with clarity.
Drawing on more than 35 years of experience across the NHS, pharmaceutical industry, MHRA and consultancy sector, I offer a focused range of services to biotech and pharmaceutical companies of all sizes.
Regulatory Strategy (UK, EU, US)
Development of robust regulatory strategies tailored to your product, target markets and development stage, with deep understanding of agency expectations and precedent.
Clinical Development Planning
Design and critical review of clinical development programmes, from early-phase through to pivotal studies, ensuring scientific rigour and regulatory acceptability.
Agency Scientific Advice Meetings
Preparation, strategy and support for scientific advice interactions with the EMA, MHRA, FDA and other health authorities, including briefing document authoring.
Orphan Drug Designation
Strategic advice and application support for orphan medicinal product designation in the EU and UK, including prevalence assessment and significant benefit argumentation.
Paediatric Investigation Plans
Preparation and negotiation of PIPs with the EMA Paediatric Committee, including waivers and deferrals, drawing on extensive experience of the PDCO process.
Regulatory Gap Analysis
Independent assessment of your regulatory dossier, clinical data package or development programme to identify gaps, risks and remediation options ahead of submission.
Clinical Overview Writing
Authoring of Module 2.5 Clinical Overviews and integrated summaries, combining scientific accuracy with a clear understanding of what regulators expect to see.
Product Lifecycle Management
Regulatory support for post-authorisation activities including variations, renewals, label updates and responses to agency questions.
Clinical Data Analysis
Critical appraisal and interpretation of clinical data to support regulatory submissions, benefit-risk assessments and strategic decision-making.
Due Diligence and Portfolio Strategy
Independent regulatory and clinical due diligence for in-licensing, acquisition and portfolio decisions, providing an objective assessment of risk and opportunity.
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