Innovation Through Expert Safety & Risk Management
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.
Pharmacovigilance
Comprehensive pharmacovigilance support including adverse event management, signal detection, aggregate reporting, case processing oversight, and post-marketing surveillance programs.
Risk Management
Development and optimization of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and proactive risk minimization initiatives aligned with global regulatory requirements.
Clinical Safety
Strategic clinical safety support throughout clinical development, including safety monitoring, benefit-risk assessment, protocol review, and safety governance.
Regulatory Compliance
Guidance and operational support for FDA, EMA, and international regulatory safety requirements, ensuring inspection readiness and sustainable compliance practices.
Safety Operations
Design and implementation of efficient pharmacovigilance systems, SOP development, workflow optimization, vendor oversight, and quality management support.
Post-Market Surveillance
Ongoing monitoring and evaluation of product safety data to support regulatory obligations, signal management, and long-term patient safety.
Safeguarding pharmaceutical innovations from lab to market through expert pharmacovigilance and clinical safety strategies that protect patients, ensure compliance, and accelerate development.
Dr. Felix Arellano brings extensive experience across pharmacovigilance, clinical safety, and global regulatory frameworks.
Assessment
We evaluate your current safety operations, compliance landscape, and development objectives.
Strategy
We design customized pharmacovigilance and risk management solutions aligned with regulatory expectations.
Implementation
We support execution through operational guidance, documentation, process optimization, and oversight.
Monitoring & Improvement
We continuously evaluate performance, compliance readiness, and emerging safety considerations to support long-term success.
We collaborate with a carefully selected network of experts and partners
