Get to know us
Minerva Regulatory Consulting's mission is to accelerate drug development across biologics — especially advanced therapies (ATMPs/CGTs) — and small‑molecule products by delivering specialised CMC expertise, high‑quality regulatory submissions, and end‑to‑end GMO application support.
We help organisations move faster and more confidently through global regulatory pathways with strategies that are clear, actionable, and commercially focused.
With a practical, implementation‑driven approach, we turn complex regulatory requirements into actionable strategies — enabling faster approvals, smoother lifecycle management, and stronger commercial outcomes.
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About
Minerva is led by Dr Lara Stevanato, a Strategic Regulatory Affairs Leader with over 20 years of experience across biotech and CRO settings. She has delivered complex global regulatory strategies for biologics such as ATMPs/CGTs, GMO applications, and small molecules, guiding programmes from early development through to approval. Her expertise spans high‑complexity submissions, hands‑on operational leadership, and strategic engagement with MHRA, EMA, and FDA. Dr Stevanato brings deep experience navigating evolving regulatory frameworks, identifying risks, and shaping strategies aligned with both development and commercial objectives.
Minerva Regulatory’s approach is grounded in practical regulatory enablement— implementing solutions that are proportionate, sustainable, and embedded within existing operations. The company ensures organisations are prepared to meet rising regulatory expectations with confidence, supporting their progression into the next stage of growth and product advancement.
