Shaum Jhansale, Regulatory Affairs, United States
With decades of experience and leveraging Pfizer’s global expertise in regulatory practices, our Regulatory Affairs team helps facilitate early engagement with regulators and offers customized submission support.
With a strong reputation for success, we are committed to supporting you, our customer, in ensuring regulatory compliance that makes peace of mind possible.
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 includes assistance with the maintenance of your approved registrations.
Our teams are fully dedicated to your product for the long-term, working 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.
Development
Commercial
Lifecycle Management
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
