George Toscano is a seasoned professional with over 20 years of experience in the pharmaceutical industry. He is an expert consultant and project manager who has worked on large international compliance projects involving corporate 483 responses, Warning Letters, Consent Decree(s), and AIP. With extensive knowledge of product development, method development, validation and transfer, Mr. Toscano has managed or overseen product development and the generation of CMC sections for regulatory submissions of ANDA's, NDA's and 505(b)2 applications. He has also provided clients with expert counsel on laboratory and manufacturing investigations, CAPA development and implementation, change control, training, stability programs and other quality systems.

As a recognized Data Integrity expert, Toscano has been involved in numerous audits and assessments to evaluate companies' systems and has assisted companies with remediation activities related to Data Integrity deficiencies and enforcement actions. Recently, he was project lead for a multi-year facility expansion and remediation project for a major Biologics manufacturer under consent decree with a successful outcome for the client.

Toscano holds a BS in Biology from the University of Central Florida and an MBA in International Business from Florida Atlantic University. He has served in various roles throughout his career, including President at TCG, VP of Quality Systems at NSF Health Sciences, Principal Consultant at Quintiles, and Director of Research at Mankuta Gallagher & Associates, among others.

Overall, Toscano's technical background and extensive industry experience have proven essential in providing clients' strategies for the implementation and remediation of quality systems to comply with FDA regulations.