Rudy Flach

  • Senior Vice President – Research and Development

Rudy brings over 24 years of experience in drug product development, analytical development, clinical support, commercial manufacturing, and regulatory strategies for IND/NDA/ANDA submissions with an extensive focus on sterile injectables.​

Rudy will oversee the company’s R&D development programs across all drug dosage platforms focusing on core development in formulation, analytical, manufacturing tech transfer and regulatory affairs strategies.​

He has extensive scientific leadership and management experience in creating and managing high performing technical teams to deliver high-quality solutions. As a Subject Matter Expert (SME) in formulation development, Rudy has developed numerous complex drug product formulations and has received over 30 ANDA/NDA approvals for the US and European markets.   ​

Rudy has held various positions at Baxter Healthcare, Teva Pharmaceuticals, Avrio Biopharmaceuticals, Alcami, Exova, B. Braun, Gilead Sciences, and Custopharm, Inc. Rudy holds a B.Sc. in Chemistry from the University of California, Irvine and a M.Sc. in Organic Chemistry from California State University, Fullerton.