Andrew Bosco

Background

About Andrew Bosco

I'm an experienced pharmaceutical development and regulatory affairs professional specializing in CMC regulatory strategy and submissions, inhalation drug product and device development, CRO/CMO vendor management, pulmonary drug delivery and inhalation sciences, and clinical program management. My areas of expertise include the following: • Module 2.3 and Module 3 for US IND/NDA/BLA Submissions • CMC regulatory strategy for small molecules, biologics, and medical devices • Inhalation drug product and device program development and management (nebulizers, pMDIs, DPIs) • CRO/CMO Project and Vendor Management • Pre-Clinical and Phase Clinical Project Management • GLP and GMP Compliance Monitoring I'm a dynamic business professional with excellent communication skills, a strong program management background and a proven ability to manage timelines and track deliverables throughout all phases of drug product development and the regulatory submission process. I focus on fostering a strong rapport and collaborative working community between internal project team members and external vendors. Allow me and my network of US and EU Regulatory Affairs experts to help you achieve your product development goals.