Powered by Pfizer, our on-site teams bring decades of regulatory knowledge across over 150 global markets.  

Functional and technical experts collaborate with you by providing data, historical expertise, and compliance insight across major health authorities worldwide. You own your strategy. We provide the expertise and data to support it. 

With regulatory experience spanning oral solids, sterile injectables, antibody drug conjugates, and microbial fermentation, Pfizer CentreOne brings execution-aligned regulatory knowledge across our global manufacturing network. 

From IND filing to global registration, our teams bring experience shaped by historical interactions with global health authorities, including: 

• FDA (CDER & CBER)
• Health Canada 
• European Medicines Agency 
• EU Nationals 
• TGA (Australia) 
• ANVISA (Brazil) 
• PMDA (Japan) 
• NMPA (China) 
• Many more 

Your intellectual property is protected by well-established, secure systems and a strong culture of confidentiality. 

With continual staff training, comprehensive controls, and decades of experience handling sensitive information across major global markets, Pfizer CentreOne provides the security and trust you need throughout your regulatory journey.