Our Regulatory Affairs professionals have decades of experience and leverage Pfizer’s global expertise in regulatory practices. The team helps facilitate early engagement with regulators and offers customized submission support.
Can Pfizer help me develop a regulatory strategy?
We sure can. Collaborate with Pfizer CentreOne and you'll get access to a team of regulatory experts who will support your filings and pre- and post-launch strategy.
Shaum Jhansale, Regulatory Affairs, United States
Our Regulatory Affairs professionals have decades of experience and leverage Pfizer’s global expertise in regulatory practices. The team helps facilitate early engagement with regulators and offers customized submission 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.
We are known for our prompt delivery of documentation, including:
We can deliver the documentation to you or, in some cases, work directly with the regulatory agencies on your behalf.
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.
ANVISA, EMA, FDA, Health Canada, MHRA, NMPA, PMDA, Korean FDA, TGA
ANVISA, Belarus, COFEPRIS, EMA/HALMED, FDA, GCC-DR, Health Canada, HPRA, Korean FDA, MHRA, PMDA, Russia MOH, TGA, Turkish MOH
AIFA, ANMAT, ANVISA, EMA, FDA, HPRA, IMB, INVIMA, Korean FDA, NMPA, PMDA, Russia MOH, Supervisory Agency Germany, TFDA, Turkish BOH
AIFA, ANVISA, Belarus, COFEPRIS, EAEU, EMA, FDA, GCC-DR, Health Canada, Kazakhstan, Korean FDA, MHRA, MOITRF, NMPA, PMDA, Taiwanese MOH, TGA, Turkish MOH