Product Development

Global Product Development

Global Product Development

PHIPL Global Product Development (GPD) supports clinical and late stage development of medicines and regulatory affairs across all therapeutic areas. It plays an important role in executing to the mandate of delivering the global portfolio. Our associates bring science and data analytics together to support various aspects of the drug development process, from clinical trial execution, data acquisition, data review, statistical analysis and reporting, regulatory affairs and submissions. Most of our GPD associates are located in Chennai and Mumbai.

We work in an open work environment that fosters collaboration and enables teams to translate advanced science and technologies into breakthrough innovations and therapies, in order to bring Breakthroughs That Change Patients’ Lives.

Global Regulatory Affairs

PHIPL Global Regulatory Affairs (GRA) delivers safe, effective, and quality Products to patients worldwide. A diverse regulatory talent pool of professionals supports Regulatory Strategy (Global, Regional & Country) and Global Regulatory Operations (GRO) for Pfizer Biopharmaceutical Group comprising of Innovative Medicines Business and Hospital Business Unit.

Regulatory Strategy teams of PHIPL support new Registrations from Concept-to-Commercialization and post approval Life-Cycle Maintenance of On-Market products in partnership with R&D, Pfizer Global Supply, Commercial, Global & Regional Regulatory teams. Multiple Regulatory Strategy teams (Chemistry Manufacturing Controls (CMC) & Non-CMC) are grouped by Platforms, Portfolios (Sterile Injectables Generics, Brands, Biologics & Biosimilars) and Therapeutic Areas.

Regulatory Operations teams of PHIPL support End-to-End Dossier Execution through multiple teams across Submissions Management, Publishing and Product License Support, Artwork Implementation, and, Labeling Process Management, thereby enabling regulatory submissions and global strategy.