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Regulatory support

Global regulatory affairs support

At Pfizer CentreOne, we support you with our global team of regulatory affairs professionals who have access  to regulatory requirements for more than 150 countries. The team has over eight decades of combined experience and provides best-in-class regulatory services.  

With access to some of the best regulatory minds in the industry at Pfizer, we can help you with your regulatory  affairs challenges.

Navigate the regulatory landscape 
with confidence

Our knowledge and experience with successful submissions cover a wide range of modalities including: 


  • Small molecule active pharmaceutical ingredients (APIs) 
  • Oral solids 
  • Large molecule biologics 
  • Sterile injectables

Speak to our regulatory experts today

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Worldwide expertise 

With access to Pfizer’s Global Regulatory Sciences network, the Pfizer CentreOne regulatory team is well-equipped to support submissions to worldwide health authorities, including:

  • FDA (CDER & CBER)  
  • Health Canada  
  • ANVISA (Brazil)

  • European Medicines Agency  
  • PMDA (Japan)  
  • TGA (Australia)

  • EU Nationals  
  • NMPA (China)  
  • Many additional agencies
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