Safeguarding Pharmaceutical
Innovation Through Expert Safety & Risk Management
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Independent pharmacovigilance, safety strategy, and
risk management for biotech and specialty pharma.

Arellano Risk Management is led by Felix Arellano, former Global Head of Safety at Roche. Depending on project requirements, services are delivered directly by Felix or through a carefully selected network of subject matter experts and partners.

We provide expert pharmacovigilance and clinical safety consulting that keeps your innovations compliant, your patients protected, and your timelines on track.

what we do

Safety Strategy

Strategic safety advisors offering services on safety strategy, governance, compliance frameworks, and long-term safety strategies.

Due diligence

Due diligence offering services on investor diligence, asset assessments and licensing supports, among others.

Operational Excellence

Including signal management, inspection readiness, mock inspections, vendor oversight, safety database evaluation and implementation, advanced analytics, risk detection and augmented safety data analytics including AI algorithms.

Safety Crisis & Special Projects

When unexpected challenges arise, organizations need experienced leadership and rapid execution. We provide expert support during safety crises, regulatory escalations, inspection findings, remediation programs, product safety concerns, and other high-priority situations.

China Market Enablement

We help Chinese companies help to attract partner deals, navigate DOJ, requirements, help plan global clinical trials, PV Agreements, etc.

中国企业国际化支持

我们协助中国企业拓展国际合作机会,支持合作伙伴洽谈与交易,协助应对美国司法部(DOJ)相关要求,规划全球临床试验,并提供药物警戒协议(PVA)等专业支持。

Leadership Development

In collaboration with the Value Add Group, our leadership development focuses on strategic thinking, executive presence, stakeholder management, organizational leadership, and change management.

Arellano Risk Management

Safeguarding pharmaceutical innovations from lab to market through expert pharmacovigilance and clinical safety strategies that protect patients, ensure compliance, and accelerate development.

Our approach

Dr. Felix Arellano brings extensive experience across pharmacovigilance, clinical safety, and global regulatory frameworks.

s

Assessment

We evaluate your current safety operations, compliance landscape, and development objectives.

f

Strategy

We design customized pharmacovigilance and risk management solutions aligned with regulatory expectations.

q

Implementation

We support execution through operational guidance, documentation, process optimization, and oversight.

v

Monitoring & Improvement

We continuously evaluate performance, compliance readiness, and emerging safety considerations to support long-term success.

We collaborate with a carefully selected and integrated network of  experts and partners

Our extensive work experience reflects our purpose,
our core
values and our culture of shared success.