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53 Quarry Road Godalming, Surrey, GU7 2RW United KingdomMinerva Regulatory Consulting 1. Who We Are Minerva Regulatory Consulting supports organisations as they transition from early scientific innovation into the complex, high‑expectation world of global regulatory requirements. We specialise in biologics including ATMPs/CGTs, GMO‑regulated products, and small molecules, ensuring programmes evolve with the clarity, structure, and regulatory maturity needed for global success. 2. Our Value Proposition Minerva enables teams to demonstrate: - Regulatory alignment from the earliest stages - CMC maturity appropriate for each development phase - Operational discipline under increasing regulatory scrutiny - Credible, inspection‑ready documentation and processes We reduce risk, accelerate progress, and strengthen the regulatory standing of development programmes. 3. Leadership Dr Lara Stevanato — Founder & Principal Consultant Strategic Regulatory Affairs Leader with 20+ years of experience across biotech and CRO environments. Expert in: - Global regulatory strategies for biologics including ATMPs/CGTs, GMO applications, and small molecules - High‑complexity CMC submissions and lifecycle management - Direct engagement with MHRA, EMA, and FDA - Navigating evolving regulatory frameworks and identifying critical risks early Dr Stevanato brings a rare combination of scientific depth, regulatory insight, and operational leadership. 4. What We Deliver Minerva provides practical, implementation‑driven regulatory enablement: - Proportionate, sustainable solutions embedded within existing operations - Clear, structured regulatory pathways aligned with development and commercial objectives - Early‑phase to late‑phase readiness for global submissions and agency interactions - Strengthened internal capability through hands‑on support and strategic guidance Our approach avoids unnecessary complexity and focuses on what truly moves programmes forward. 5. Why Organisations Choose Minerva Deep expertise in high‑complexity, high‑scrutiny modalities - Proven track record from FIH to approval - Ability to translate scientific ambition into regulatory‑credible strategies - Practical, execution‑focused support that integrates seamlessly with existing teams - Confidence and readiness for global submissions, inspections, and agency meetings 6. Our Impact Minerva positions organisations to: - Advance development programmes with confidence - Meet rising regulatory expectations without disruption - Strengthen credibility with regulators and investors - Build the foundations for long‑term growth and product advancement
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