Daniel Loeven

Technical Area Focus:
Regulatory Affairs; Quality Assurance; Chemistry, Manufacture and Controls; Product Development Planning; FDA licensing

Loeven is the Director, Regulatory Affairs and Quality, with responsibility for ensuring compliance with FDA and DEA regulations of research conducted worldwide. Loeven supports Pharmaceutical Development by providing advice on FDA and DEA requirements, Auditing for compliance with Good Clinical Practice (GCP) regulations and with Good Manufacturing Practices (GMP) regulations on an on-going basis during development and clinical study of treatments. With thirty years of experience in pharmaceutical quality and regulatory issues, Loeven has been involved in numerous drug development projects and the launch of many drug products. Loeven holds a BS is Chemistry from SUNY Oneonta and an MS in Drug Regulatory Affairs from Long Island University, Brooklyn.