Global regulatory affairs support  

At Pfizer CentreOne, we support you around the globe with our team of regulatory affairs professionals who have access to regulatory requirements for more than 150 countries. The team has over 80+ years of experience and provides a best in class end-to-end regulatory service.        

Our service will provide you with an advisor to help you navigate your regulatory affairs journey from development to submission and commercialization. We will look to partner with you to use our extensive knowledge and experience with submissions and regulatory approvals to help guide your submission content. With access to some of the best regulatory minds in the industry at Pfizer, we can help you with your regulatory affairs challenges.

Our knowledge and experience with successful submissions covers 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

Why choose us?

Partnering with us gives you access to Pfizer's Global Regulatory Sciences network including tools, systems and resources that Pfizer has build based on actual experience.

  • Best in class regulatory experience – Given the access our regulatory team has to Pfizer’s Global Regulatory Sciences network; we can provide the necessary support. 
  • Trusted partnership - We understand the importance of responding quickly to challenges in your development and regulatory affairs (RA) journey. You can rely on Pfizer CentreOne RA in your time of need.
  • Eliminate an unnecessary expense – If you are already utilizing a CDMO for CMC RA consultation or project management purposes, you may be able to eliminate an unnecessary expense by partnering with our team. Our RA professionals act as both a CMC RA consultant providing the right strategy and knowledge to help you ensure CMC practices are in accordance with current expectations of regulatory bodies, and as a RA Project Manager leading the end-to-end submission planning, coordination, monitoring, and execution of assigned deliverables.
  • Budgeting made simple – We aim to work with your budgets, we take into consideration your needs for the upcoming year, and we will generate a simple monthly cost for our services. 


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