Comprehensive support

We provide customized assistance for your regulatory submissions and supporting documentation including specifications, analytical methods, method validation reports, and certificates of analysis.  If documents are not needed for submission, we provide a complete information summary that has gone through data verification.  

Post-approval submissions support include assistance with the maintenance of your approved registrations. 

Our team works flexibly to meet your timing needs all around the globe. 

In-house team ensures speed and accuracy

We are known for our prompt delivery of documentation, including: 

  • Safety data sheets  
  • Stability reports 
  • Regulatory open file  
  • Standard Statements and Declarations 

We can deliver the documentation to you or, in some cases, work directly with the regulatory agencies on your behalf.  

Development

  • Scope opportunities
    • Due diligence
  • Regulatory strategy
    • Clinical trial application author and support
  • Quality and supply agreement review/input

Commercial

  • Authoring/review of the initial submission
  • Review Agency meetings
    • Serve as liaison with its CMC and QA
    • Support for deficiency responses
  • Labeling development for drug products
  • Support for launch

Lifecycle management

  • Post-approval submissions
    • Strategy development
    • Documentation
    • Authoring/review
  • Annual reports
    • Due date tracking
    • Maintenance
    • Compilation
  • International registration support
  • Review and assessment of change controls
  • Management of associated drug product DMFs

Confidentiality and Certifications

Our dedicated regulatory resources protect confidentiality. Proprietary information is not shared outside of Pfizer CentreOne. Customer submission documents are not housed in Pfizer regulatory affairs systems and CMC documents are restricted to authorized personnel. 

Small Molecule APIs

ANVISA, EMA, FDA, Health Canada, MHRA, NMPA, PMDA, Korean FDA, TGA

Large Molecule Biologics

ANVISA, Belarus, COFEPRIS, EMA/HALMED, FDA, GCC-DR, Health Canada, HPRA, Korean FDA, MHRA, PMDA, Russia MOH, TGA, Turkish MOH

Oral Solids

AIFA, ANMAT, ANVISA, EMA, FDA, HPRA, IMB, INVIMA, Korean FDA, NMPA, PMDA, Russia MOH, Supervisory Agency Germany, TFDA, Turkish BOH

Sterile Injectables

AIFA, ANVISA, Belarus, COFEPRIS, EAEU, EMA, FDA, GCC-DR, Health Canada, Kazakhstan, Korean FDA, MHRA, MOITRF, NMPA, PMDA, Taiwanese MOH, TGA, Turkish MOH