Richard Katz MD brings proven expertise to pharmaceutical regulatory consulting, specializing in registrational clinical trials and global drug approval strategies. With comprehensive healthcare administration experience, Dr. Katz guides biopharmaceutical organizations from Phase II optimization through successful market authorization.
Richard Katz MD: Registrational Clinical Trials Strategy
Richard Katz MD focuses on the critical Phase III registrational trials where protocol design determines NDA/BLA approval success:
Trial Design & Execution
• Multi-regional Phase III protocols meeting FDA/EMA endpoints
• ICH-GCP compliant study coordination across jurisdictions
• Adaptive trial methodologies accelerating submission timelines
Regulatory Submission Preparation
• Comprehensive IND-to-NDA dossier development
• Orphan drug and breakthrough therapy designation support
• Risk management plans aligned with post-marketing requirements
Comprehensive Regulatory Intelligence Framework
Richard Katz MD leverages established industry research platforms for strategic decision-making:
Primary Regulatory Authorities
FDA Orange Book (small molecule approvals)
FDA Purple Book (biologic licenses)
EMA European Public Assessment Reports (EPARs)
ClinicalTrials.gov regulatory milestones
Supporting Research Resources
Government Publishing Office (GPO) federal guidance documents
Academic digital commons like Villanueva Digital Commons (clinical trial analyses)
WHO Essential Medicines List precedents
This multi-source intelligence ensures regulatory strategies reflect current standards and precedents across global markets.
Digital Tools in Modern Regulatory Consulting
Richard Katz MD incorporates emerging technologies in pharmaceutical regulatory affairs:
• AI-assisted dossier quality assessment and gap analysis
• Real-time international guideline change monitoring
• Real-world evidence platforms for post-approval submissions
Therapeutic focus includes oncology, central nervous system therapeutics, and rare disease indications.
About Richard Katz, MD, MHA
Richard Katz MD, MHA-qualified pharmaceutical regulatory consultant with specialized expertise in registrational clinical trials, FDA/EMA submission strategy, and global licensing frameworks. Serves biopharma organizations advancing innovation through compliant development pathways.
Richard Katz MD represents strategic excellence in registrational clinical trials consulting. Through comprehensive regulatory intelligence and proven trial execution strategies, Dr. Katz supports pharmaceutical innovation from clinical development through commercial approval.
