Andrew Papas, Ph.D.

Andrew Papas provides leadership and guidance on global regulatory affairs, quality, and drug development programs. His unique combination of expertise in global regulatory affairs, industry leadership, management and laboratory science allows him to provide clients with strategic and technical assistance in the development of innovative global regulatory solutions and practical business-minded solutions for pharmaceutical and biologics firms.

Dr. Papas has particular expertise in biologic and combination product development, and pre- and post-approval changes for orphan and mainstream drugs. Dr. Papas applies his extensive chemistry, manufacturing and controls (CMC) experience to the development of strategic regulatory pathways for pharmaceuticals and biologics in the U. S. as well as in international markets.

Dr. Papas was formerly a global regulatory affairs executive at various international pharmaceutical firms, where he was responsible for international CMC regulatory strategy for innovative pharmaceutical, biologic and combination products. He has managed or overseen various types of regulatory submissions to domestic and international regulatory agencies for novel products and molecular entities. Dr. Papas also managed analytical R&D laboratories earlier in his career and served as a chemist specialist for the U.S. Food and Drug Administration (FDA), where he supported CDRH medical device PMA evaluations, reviewed drug and radiopharmaceutical NDAs, supported the CFSAN market-based program and assisted with agency investigations of suspected product contaminations.

Dr. Papas was previously the Senior Director of Regulatory Affairs for the Pharmaceutical and Biologics Practice at Becker & Associates Consulting.