Robert Kaster brings more than 30 years of pharmaceutical/biopharma experience from both small and large organizations (including Wyeth and DuPont Pharma) and has been consulting since 2007. He holds a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science (University of the Sciences in Philadelphia) and is a registered pharmacist. Rob is also an American Society for Quality (ASQ) Certified Quality Auditor (CQA). His background includes CMC Regulatory Affairs, CMC drug product formulation development/manufacturing and GXP Quality Assurance. Strengths include CMC regulatory submission compilation (US/ex-US) and CMC FDA strategy/meetings as well as CMC product/process development/validation clinical through commercial manufacturing. His Quality experience includes QA/Compliance program development/oversight, extensive auditing (facility-Pharma and CMO/CRO, documents, regulatory submissions, PAI-readiness), generation of SOPs, protocols, validations, CAPA assessment and quality agreements. Rob has successfully worked with numerous multi-disciplinary teams, project lead on many occasions with a focus on client’s needs and deliverables.
Officers
G. Alexander Fleming, MD
Executive Chairman
Thomas Seoh
President and Chief Executive Officer
Clinical Development
Regulatory Affairs
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Pre-Clinical
CMC, Formulation/Process Development & Sourcing
Medical Device
QA/QC
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Medical Writing/Electronic Submissions
Process & Innovation Management
Elizabeth Whalley Buono, BSN, RN, MBA, JD
Commercializing and Business & Corporate Strategy
Founders