DevRx Consulting
Senior Consultant for Regulatory Affairs, Quality Assurance, and Drug Development Strategy
Natalie
McClure, PhD
Regulatory Affairs and Quality Assurance
Dr McClure is
a regulatory affairs consultant with extensive experience in drug development,
regulatory affairs, and quality assurance.
She has filed more than 50 INDs, and CTAs and supervised regulatory
affairs and clinical research for clinical trials in the US, Canada, Western
Europe, Eastern Europe, Russia, India, and China. Natalie has directed drug
development programs for new chemical entities and controlled release dosage
forms.
Dr. McClure
obtained her PhD in Organic Chemistry from Stanford University in 1979 and her
BS in Chemistry from the University of Michigan and then spent 10 years working
for Syntex Research, a pharmaceutical company later acquired by Roche, working
in the process development laboratories on new synthetic approaches to prostaglandins
and large scale peptide synthesis.
Over the past
40 years, Natalie has worked with multiple small companies to establish their
internal regulatory affairs and quality assurance systems. One recent accomplishment was the approval
for an NDA for Gocovri® (amantadine) extended release capsules for the
treatment of dyskinesia in Parkinson’s disease patients receiving
levodopa-based therapy, with or without concomitant dopaminergic
medications. This orphan drug represents
the first NDA approved for this indication.