Mr. Prabhu P. Raju is a highly accomplished regulatory and compliance expert with over 34 years of experience at the U.S. Food and Drug Administration (FDA) and as an independent consultant. His career spans advanced manufacturing, biological product safety, international regulatory inspections, and public health leadership.  

Prabhu has held pivotal roles in the approval and oversight of critical medical products, including COVID-19 vaccines and novel gene/cell therapies, and has been recognized with numerous FDA awards for his leadership and contributions to public health. He is known for his expertise in inspectional and investigational techniques, regulatory policy development, and cross-functional collaboration with industry, academia, and global regulatory authorities. His work has directly impacted the approval and safety of high-profile biological drugs, medical devices, and advanced therapies worldwide. 

Key Areas of Expertise 

• FDA Regulatory Inspection & Compliance: Over 300  inspections of licensed biological products and medical devices, including domestic and international sites. 

• Advanced Manufacturing & Emerging Technologies: Program Expert for FDA’s Emerging Technologies Advanced Manufacturing (ETAM) Team; subject matter expert in advanced manufacturing processes, 3D printing, AI in pharma, and novel control/testing strategies. 

• Biological Product Safety: Authority on manufacturing and inspection of vaccines (COVID-19, influenza, bacterial, viral), plasma derivatives, cell/gene therapies (CAR-T, HPC, cord blood), and in-vitro diagnostics. 

• International Public Health & Foreign Inspections: Led high-profile foreign inspections in Europe and Asia; instrumental in the approval of the Novavax COVID-19 vaccine and other global products. 

• Leadership & Program Management: Acting Staff Director for Team Biologics; led teams, set priorities, and managed complex inspectional assignments during critical public health events. 

• Training & Mentorship: Developed and delivered FDA training modules; mentored new investigators; coordinated industry and academic training collaborations. 

• Regulatory Policy & Guidance Development: Contributor to FDA guidelines, compliance programs, and international regulatory harmonization efforts (e.g., Annex 1, ICH9, ICH13, EU Annex 16). 

• Awards & Recognition: Multiple FDA Honor Awards, including the Commissioner’s Citation for COVID-19 vaccine work, and numerous performance and leadership awards. 

• Technical & Scientific Expertise: Certified at the highest levels in drug and medical device inspection; advanced training in biomanufacturing, data integrity, and quality systems. 

• Professional Affiliations: Active member and contributor to ISPE Northwest, PDA Northwest and Life Science & Tech Consultants Association.