Lindsey Saunders Gorka

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PfiZer
Associate Director in Global CMC
Lindsey Saunders Gorka is an Associate Director in Global CMC at Pfizer, located in Peapack, New Jersey. She supports the development of CMC regulatory strategies for clinical and registration global filings of innovative medicines. Prior to joining Pfizer, she was a CMC Reviewer in the Office of New Drug Products at the FDA. Lindsey has a BS in chemistry from Brandeis University and a PhD in chemistry from Yale University. She also completed a postdoctoral fellowship at the National Cancer Institute. Lindsey earned her Regulatory A airs Certification in 2015 and has previous regulatory experience working at Technical Resources International. Lindsey is currently an active member of the IQ Co-processed APIs Working Group.

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The latest ICH guideline, ICH Q12,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019.