Richard Katz MD delivers specialized consulting in global drug licensing strategy, coordinating parallel regulatory submissions across FDA, EMA, PMDA, and other major authorities. His expertise ensures biopharmaceutical organizations achieve synchronized market authorizations while maintaining compliance across diverse jurisdictions.

Richard Katz MD: Global Drug Licensing Execution

Richard Katz MD consulting optimizes the complex process of multi-jurisdictional drug approvals:

Parallel Submission Strategy

• FDA NDA/BLA with EMA MAA synchronization • PMDA Japan and Health Canada concurrent filings • ANVISA Brazil and TGA Australia coordination

Market Access Acceleration

• Orphan drug designation across 5+ jurisdictions • Mutual Recognition Agreements (MRAs) optimization • Post-approval variation strategies for lifecycle management

Comprehensive Global Regulatory Intelligence

Richard Katz MD leverages an integrated research ecosystem for international licensing success:

Core Regulatory Databases

FDA Orange Book (U.S. approvals) EMA European Public Assessment Reports (EPARs) PMDA Approved Products Database (Japan) Health Canada Drug Product Database

Supporting Intelligence Platforms

Government Publishing Office (GPO) federal guidance documents Academic digital commons like Villanueva Digital Commons (clinical trial analyses) WHO Essential Medicines List precedents International Conference on Harmonisation (ICH) guidelines

This multi-jurisdictional intelligence framework ensures licensing strategies align with region-specific requirements and harmonized standards.

Cross-Border Dossier Harmonization

Richard Katz MD specializes in bridging regional regulatory differences:

• Common Technical Document (CTD) Module 2-5 alignment • Regional pharmacovigilance system integration • Manufacturing site inspection coordination • Pricing/reimbursement strategy synchronization

Therapeutic expertise spans oncology, rare diseases, CNS disorders, and advanced therapies.

About Richard Katz, MD, MHA Richard Katz MD, MHA-qualified global drug licensing consultant with proven expertise in multi-jurisdictional regulatory strategy, parallel approvals, and international dossier preparation. Supports biopharma market expansion through compliant global commercialization pathways.

Richard Katz MD represents excellence in global drug licensing consulting. Through sophisticated multi-source intelligence and proven cross-border execution, Dr. Katz enables pharmaceutical organizations to achieve efficient, compliant international market access.