Deploying the PRACT methodology (Pharmacovigilance, Regulatory Affairs, Clinical Trials) to translate complex scientific data into actionable regulatory execution for Pharma & MedTech.
In the life sciences, bridging the gap between rigorous scientific data and complex regulatory pathways is the most expensive bottleneck for product development.
I combine a highly-cited academic background in oncology and RNA therapeutics with hard, certified regulatory expertise. This allows me to translate complex preclinical and clinical data directly into actionable regulatory strategy (EU MDR, FDA) and pharmacovigilance compliance.
Years in Life Sciences
Peer-Reviewed Publications
Pharma & MedTech Focus
My expertise is structured across three distinct pillars to ensure end-to-end clinical and regulatory success.
Specialized drug safety signal detection and competitive safety analysis using global databases (FAERS, EudraVigilance) to mitigate pre-clinical and post-market risk.
Automated tracking of shifting FDA/EMA/MDCG guidelines and deep strategic negotiation to accelerate submission pathways and maintain market compliance.
Rigorous systematic literature reviews, Target Trial Emulation, and Post-Market Clinical Follow-up (PMCF) strategy backed by robust clinical data modeling.
Demonstrating capabilities through targeted research and data engineering.
A comprehensive signal detection report analyzing ocular adverse events associated with Antibody-Drug Conjugates using the FDA Adverse Event Reporting System (FAERS). Currently in preparation for publication in Drug Safety.
Request Executive SummaryA highly structured, filterable repository aggregating complex medical device and pharmaceutical regulatory standards (ISO, MDCG, FDA) to rapidly assess compliance impact.
View Database ArchitectureA custom-built data repository structuring complex genomic and clinical trial data surrounding DDR programs for oncology therapeutics targeting ALT and ATRX mechanisms.
Discuss MethodologyWhether you want to discuss a specific regulatory challenge, explore the PRACT methodology, or connect regarding industry collaborations, let's start a conversation.