Health innovation due diligence with direction
What We Do
Brújula | Brúixola provides independent expert benefit–risk due diligence for investors, acquirers, and health innovators.Whether you're assessing a digital platform, diagnostic tool, therapeutic product, or full company, we help you cut through complexity - and understand the risks that truly matter.We review:
Clinical development plan
Benefit–risk profiles based on robust data review (toxicology, clinical, safety, mechanism of action and other similar products)
Safety data, safet concerns, and full literature review
Regulatory history and strategic roadmap
Real-world viability
Systems alignment (clinical and safety databases)
We deliver expert assessment of the asset’s clinical evidence, safety position, and regulatory path - highlighting risks that could impact development or value.You will receive clear, actionable insights in a written report with associated meeting to discuss proposed next steps. If there are clinical or regulatory risks, then potential mitigation plans will be presented.
Why It Matters
Due diligence in health innovation involves complex, often fragmented data - where critical safety and benefit–risk insights can be missed, or raised too late.Delay can derail deals and missed risks can trigger compliance issues, expose patients to avoidable harm or put trials on clinical hold soon after acquisition – or stop whole development programs. Clinical and safety expertise should be integrated early and jointly - not treated as a formality or an afterthoughtWe believe clinical and safety input should come early, not as a tick-box or afterthought.
Who we support
Investors and Venture Capital FirmsMost early-stage biotech teams are small - often led by brilliant scientists, not pharmaceutical physicians. We provide expert due diligence on safety, benefit–risk, and regulatory aspects that are outside their core expertise, helping VCs make informed funding decisionsThis includes:
Reviewing available clinical data, protocols, informed consent forms, and safety documentation
Analyse case-level safety data, identify known and emerging safety signals, safety concerns, and evaluate alignment between the product’s mechanism of action, trial design, and regulatory path.
Identifying weaknesses in benefit–risk positioning or regulatory assumptions
Assessing prior scientific advice, agency feedback, or interactions that may shape future negotiations
Flagging risks that could result in trial delays, protocol amendments, regulatory pushback, or loss of strategic value
You will receive a Board ready report, with summary of key data and proposals for next steps. If risks are identified, then detailed proposed risk mitigation strategies will be included. If required, we can attend the Board meeting.
We help you move forward with clarity - or step back with confidence.
Companies Planning an Acquisition
We provide strategic benefit–risk due diligence for companies considering an acquisition - whether it’s a single product, a platform, or a full pipeline.You’re not just acquiring data- you’re inheriting benefits and risks. We help you understand what’s transferable, what’s missing, and what could later become a regulatory or operational problem.This includes:
Reviewing safety data packages, clinical protocols, literature, and known signals and safety concerns.
Identifying incomplete documentation or poor data governance that could impact transfer
Analysing trial design and informed consent materials for regulatory exposure
Reviewing prior regulatory interactions (e.g., scientific advice, conditional feedback, orphan designations) and flagging misalignment with the acquirer’s development plans
Assessing what needs to be secured via contract -pharmacovigilance data, safety governance agreements, or commitments with CROs and vendors
We highlight risks, yes - but more importantly, we help you solve them. Before close. With a clear, practical transition plan.
Companies After an Acquisition
After an acquisition the hardest part often starts after the deal closes.Often the assets are acquired from a small start-up with limited senior safety experience.We conduct full 360° post-acquisition reviews to identify what’s been inherited, what’s missing, and what could undermine compliance, development, or patient safety.This includes:
Reviewing raw safety data, case narratives, signal assessments, and literature.
Comparing product labels, informed consent forms, and investigator brochures
Assessing compatibility with your own safety systems, QMS, and governance structure
Identifying legacy risks that may require regulatory updates or commitments
Flagging missing data, reporting gaps, or inconsistencies across documents and systems
If needed, we help your teams:
Raise safety queries with the clinical sites to understand key cases better
Open safety signals and write safety signal reports
Rewrite protocols or IBs
Align safety language across global submissions
Prepare risk communication strategies or escalation plans
Assist with migration of safety data
Prepare pharmacovigilance agreements
Our goal is to protect your company, and patients, before regulators or clinical sites raise concerns.Transitions in safety and clinical systems carry real risk - especially when teams change or processes aren’t clearly handed over. We help uncover what’s been missed, fix it, and protect your development path.
Risk assessment and mitigation: Review safety data, do literature review and consider other products including those in post-marketing phase and whether current protocol needs updating based on an up to date risk assessment.
Safety System Migration: We review systems and workflows to ensure continuity, data integrity, and compliance. Oversee the migration plan if required,
Unreported AEs/SAEs: We identify backlogs, legacy data, and verbal reports to investigators that were never formally logged. Retrain site staff if needed.
Clinical Database Handover: We assess how clinical data and responsibilities are transferred to avoid gaps that affect future trials. If there is to be a change in clinical database this needs implementation.
PI Communications: We check that safety concerns raised by investigators have been properly documented and followed up.
Real-world example
In one case, several SAEs had been reported verbally to investigators but never entered into the safety system. We identified the issue before inspection, retrained staff, and helped implement new processes to ensure compliance going forward.In another, an ongoing phase 1 study had to be halted soon after acquisition because of a serious adverse event. In the period from when the protocol had first been written and the product acquired more information on a specific risk had become available in the public domain but the protocol had not been updated. The patient experienced a significant SUSAR and the study was put on hold whilst the protocol, IB and other documents were updated.
Startups Preparing to Raise or Be Acquired
We work with startups preparing for investment, acquisition, or technical due diligence - often at a pivotal moment in their lifecycle.These companies typically have strong innovation - platforms, therapeutics, or diagnostics - but haven’t yet had to defend their safety or regulatory positioning under formal review. This is where our independent safety and regulatory expertise becomes critical.We help startups identify and address issues that can lead to hesitation or deal failure. This includes:
Reviewing all available clinical and safety-related materials, including serious adverse events, signal management, protocol safety language, and patient-facing documentation
Evaluating the credibility of the benefit–risk narrative, based on mechanism of action, existing data, and projected use
Assessing trial design, data collection methods, and endpoints for safety-related vulnerabilities or misalignment with likely regulatory expectations
Checking for missing or outdated materials, such as IBs, DSURs, regulatory correspondence, or signal documentation
Reviewing any scientific advice or regulatory interactions for consistency with the claims being made to investors or potential partners
Identifying exposure in communications, particularly overpromising or disconnects between internal documentation and public claims
We also support teams in preparing for formal due diligence meetings -especially where safety, clinical design, or regulatory maturity are likely to be scrutinized.The result: a stronger, more defensible story, reduced risk of reputational damage, and increased confidence from those across the table.You don’t need to fix everything. You just need to show you understand where there are gaps -and what plans are in place to close them.
Our Difference
At Brújula | Brúixola, we bring decades of experience in clinical, safety, and regulatory roles - and we know how and where things go wrong. We help you ask better questions, spot what’s missing, and avoid common mistakes before they cost time, funding, or patient safety.We deliver due diligence with clarity, sound judgment, and deep experience - protecting patients, development programs, and your investment.
About Innovigilancia
Innovigilancia SL was founded by a senior safety physician with nearly 20 years of experience across the full product lifecycle - from preclinical to post-marketing. She is supported by staff with minimum of 4 years in pharma industry and some with more than her, in different safety roles.We’ve supported everything from four-person biotechs to large pharma companies like GSK, Sanofi and Takeda. We work across all sectors of health innovation - from traditional pharmaceuticals to cutting-edge healthtech.Our services are shaped by the recurring gaps we've observed over the years, all with a single goal: improving patient safety through focused, strategic leadership