Independent benefit–risk leadership for pharmaceutical companies, biotechs, and investors at the moments where evidence is incomplete, consequences are material, and decisions must be defensible.
When a new signal breaks — whether a hepatic reaction, severe cutaneous event, or unexpected pattern in your data — the window for proportionate, defensible action is short. Innovigilancia provides immediate senior medical assessment, including complex reactions such as DILI and DRESS, to support clear governance decisions before they escalate into regulatory, development, or commercial consequences.
Licensing, acquisition, and investment decisions hinge on an honest assessment of what a safety or efficacy profile actually means — not what a data room says it means. Innovigilancia provides independent medical judgement on benefit–risk at decision-critical timepoints, including first-time-in-man evaluation, high-risk EU submissions, and pre- or post-deal asset assessment where regulatory or safety risk carries material value implications.
PRAC referrals, inspection preparation, urgent EMA queries, and benefit–risk governance remediation require senior medical leadership that understands both the science and the regulatory context. Innovigilancia supports organisations that need experienced, independent oversight — including interim QPPV cover, executive-level benefit–risk advisory, and proportionate risk-minimisation strategy — when internal resource is insufficient or an independent voice is needed.
Innovigilancia was founded to provide the kind of independent senior medical judgement that organisations need at high-stakes moments — but rarely have available internally at short notice.
We work selectively, on assignment, with pharmaceutical companies, biotechs, and investors facing situations where the evidence is evolving, the regulatory or commercial consequences are significant, and medical decisions must be both sound and defensible over time.
Our engagements are typically short, intensive, and focused on clarity — giving leadership teams and investors the independent medical direction they need to act with confidence.
Over 20 years across clinical development, pharmacovigilance, and global benefit–risk governance
Senior roles including Global QPPV, Head of Safety, and Interim CMO across pharma and biotech
Specialist expertise in complex hepatic and severe cutaneous reactions, including DILI and DRESS
Medical benefit–risk input for first-time-in-man, high-risk EU submissions, and post-approval safety governance
Independent medical assessment for licensing, acquisition, and investment due diligence
The situations that require independent medical judgement are rarely straightforward. Evidence is often incomplete, timelines are compressed, and the cost of getting it wrong — to patients, to programmes, to asset value — is material.
Innovigilancia does not provide comfort. We provide clarity. Our medical assessments are grounded in the evidence as it stands, governed by what is proportionate and scientifically defensible, and designed to hold up to regulatory, legal, and clinical scrutiny over time.
Engagements are selective. We take on work where our involvement makes a genuine difference to the quality of the decision — and where the decision genuinely matters.
Innovigilancia works with a limited number of clients at any one time. If you are facing a situation that requires immediate senior medical input, we would welcome a direct conversation.
info@innovigilancia.euInnovigilancia SL is registered in Barcelona, Spain.
Engagements are available globally, delivered remotely or on-site.