Innovigilancia provides senior independent medical leadership to pharmaceutical companies, biotechs, and investors facing complex benefit–risk decisions, whether for regulatory submissions, post-acquisition safety reviews, , or benefit–risk governance. We excel where the evidence is difficult to interpret or scientifically complex, the regulatory consequences are significant, or a safety event demands immediate medical leadership.
Independent signal assessment from routine signal management reports to urgent signal evaluations including EMA Emerging Safety Issues.
We have specific expertise in Drug Induced Liver Injury (DILI), Serious Cutaneous Adverse Reactions (SCARs) including DRESS, and programs with low numbers of cases such as rare diseases and oncology when qualitative assessments and hypothetical mechanism of action are key.
Work can follow from an Innovigilancia-led signal evaluation or be commissioned independently. We develop first-time Risk Management Plans for EMA Marketing Authorisation Applications, updates in response to new safety information or regulatory request, and additional risk minimisation measures including DHPCs.
. All recommendations are scientifically defensible and proportionate, designed to satisfy regulatory scrutiny without unnecessary restriction of patient access.
Robust benefit–risk governance is the foundation of a well-run safety system. Innovigilancia provides executive-level oversight, QPPV leadership, and independent advisory to organisations whose governance requires strengthening, whether following regulatory feedback, a change in leadership, or rapid pipeline growth.
For companies with developing pharmacovigilance teams, we offer an ongoing senior advisory relationship, providing the medical resource that sense-checks decisions and ensures advice reaching board level is accurate, defensible and pragmatic.
For regulatory interactions, we can lead strategy discussions, requests for information responses, and meetings including briefing documents. We can support inspection preparation including preparing the team and being present at the inspection.
Investment and licensing decisions turn on the quality of the medical assessment behind them. Innovigilancia provides independent evaluation of safety and efficacy data at any point in the product lifecycle, supporting mergers and acquisitions, in-licensing decisions, and asset acquisitions where an honest reading of the benefit–risk profile is essential to understanding true asset value.
Where the data room does not tell the full story, we find what it does not say. Where risks are identified, we do not stop at flagging them, we propose solutions, whether that means additional risk minimisation, protocol modifications, or a revised regulatory strategy.
After closure of the deal, safety data must be transferred into the acquirer's safety database. This is the single most important opportunity to review source data, ensure cases were coded correctly, and establish whether signals were missed under previous management. It is also, consistently, the opportunity that is missed.
Innovigilancia conducts structured post-acquisition safety data reviews, completing outstanding signal evaluations and recommending protocol modifications or other actions where necessary — protecting the acquiring organisation, its subjects, and its patients.
Before a submission reaches a regulator, a comprehensive independent review can identify weaknesses that a CHMP or FDA assessment team is likely to question. Innovigilancia leads full critical appraisals of submissions and dossiers, drawing on medical, CMC, regulatory, and where relevant commercial expertise, assembled around the specific needs of each document.
We review Marketing Authorisation Applications, New Drug Applications, Periodic Benefit–Risk Evaluation Reports, Risk Management Plans, Regulatory Questions and Information Requests, and briefing documents for FDA or CHMP meetings. For organisations with multiple assets, we offer portfolio triage. Engagements are typically three to five days and available at short notice.
Every Innovigilancia engagement can be extended into a facilitated executive decision meeting bringing your leadership team together to work through findings, align on a course of action, and leave with a documented, defensible plan. Meetings are particularly valuable where portfolio triage decisions need to be made across multiple assets, where leadership must align on regulatory strategy, or where a benefit–risk position needs to be agreed before it is presented to a regulator or board. Meetings are available at your location or at a curated private venue in Catalonia, fully arranged by our team.
Innovigilancia was founded to provide the kind of independent senior medical leadership that organisations need at critical moments — but rarely have available internally at short notice. We can provide QPPV or Head of Safety functions on an interim or ongoing basis, or engage as an independent expert at a defined point in a programme.
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 precision — giving leadership teams and investors the independent medical direction they need to act with confidence.
Innovigilancia does not tell clients what they want to hear. We tell them what the evidence shows without inflating or minimising risk beyond what the data supports.
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.