What we do...
At The Nicotine Experts, we provide strategic, regulatory, medical, and commercial expertise across the entire lifecycle of nicotine replacement therapy and adjacent self-care innovations. Our team of experts bring decades of experience in pharma and consumer health, working together to tackle complex challenges - from product development to launch and beyond.
Product Feasibility, Development & Innovation
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Concept development and clinical positioning for new NRT products
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Expertise across multiple dosage forms: gum, patch, lozenge, spray, inhaler and more..
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Consumer insight integration and claims strategy
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Digital health and behavioural support integration
Medical Affairs & Clinical Strategy
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Clinical study design (PK, PD, efficacy, reduction-to-stop, etc.)
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Medical writing: protocols, study reports, IBs, publications
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Health authority engagement (MHRA, EMA, FDA)
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Data interpretation, publication planning, and real-world evidence
Training & Expert Review
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Internal and external training (HCP education, internal upskilling)
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Claims review and promotional material sign-off (AdverCheck)
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Advisory board design and moderation
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Scientific speaker preparation and briefing
Regulatory Affairs & Market Access
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Global regulatory strategy and dossier preparation
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CMC expertise
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Clinical trial application and IMPD development
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Rx-to-OTC switch strategy and execution
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Trade association and pharmacopeial engagement
Commercial & Brand Strategy
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Global brand positioning and lifecycle strategy
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P&L responsibility and commercial planning
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Consumer and HCP marketing strategy
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Emerging market development and launch support
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Future risk mitigation strategy
M&A and Due Diligence Support
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Strategic product and pipeline evaluation
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Clinical, regulatory, and CMC risk assessment
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Review of claims, data packages, and dossiers
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Post-deal support for integration and brand optimisation