Technical And Regulatory Support
The Value of Technical Development & Regulatory Affairs
One of the advantages for customers working with Pfizer CentreSource is access to our Technical Development and Regulatory Affairs (TDRA) team. This function is arguably one of the most important value-added services we provide. TDRA provides technical and regulatory information to qualify, register, and support PCS products globally.
Specialized, Proactive Support
This experienced team is a globally integrated organization that provides to customers continuous surveillance of evolving, global regulatory and cGMP requirements, and writes and maintains worldwide registration documents.
Staff experts in engineering, molecular biology, pharmaceutical development and project management help customers manage their scientific and regulatory issues on a proactive basis. TDRA handles, among other things:
- Technical package
- Technical facilitation
- Quality agreements
- Investigation support
- Customer audits/inquiries
- Supply team feedback
Access to Technical Excellence
The level of investment in proven technology and processes that are needed to serve customers today is daunting. PCS customers have access to a number of facilities that are best-in-class within the Pfizer manufacturing network – Pfizer’s "Centers of Excellence" in fermentation, pharmaceutical manufacturing, steroid production, biologicals, and other key areas important to the industry.