Jeff Pudlo, PhD

Jeffrey Pudlo provides developmental, operational, technical, regulatory, quality, project management, and business support to the healthcare products industry worldwide.  He specializes in the areas of active pharmaceutical ingredient (API) development, drug product development, tech transfer, analytical/method development, QC and stability testing, control strategy design and implementation, process validation, chemistry, manufacturing and controls (CMC) development management, CMC regulatory submissions, GXP compliance, quality systems, diligence/quality audits and operations/project management.  His experience includes small molecule pharmaceuticals, peptides, biologics, and medical devices.  Prior to joining SciLucent, Jeff worked at a number of pharmaceutical and medical device companies where, in addition to providing technical and strategic support to pharmaceutical companies, he was involved in the development of numerous early-, mid-, and late-stage development projects resulting in a number of successfully approved commercial drugs and devices.  Jeff works with clients and cross-functional teams to ensure efficient development plans and execution and product development management.  He is an expert in regulatory submission/report preparation; quality system development and implementation; compliance auditing and remediation; market and licensing due diligence reviews; and scientific/regulatory issue research, analysis, and submission/report preparation.  Jeff has a PhD in Organic Chemistry from the University of Michigan.