Over three decades of physician and IND/NDA clinical research and development consulting expertise.
Previously held clinical development positions at J&J, Nektar Pharmaceuticals, and Jazz Pharmaceuticals. Previously also served as Medical Director of Pain and Addiction Medicine.
Therapeutic areas: CNS, psychiatry, pain (chronic and acute), neurology, and oncology.
VP Regulatory Affairs
Over 15 years in the regulatory and clinical development realms.
Previously held clinical development positions/regulatory affairs positions at J&J, Roche Diagnostics, and several small biotech companies. Previously also served as Global Medical Directory of Neurology.
Therapeutic areas: CNS, neurology, GI and oncology.
Global Head of Quality
Strong Quality Leader with over 25 years experience in implementing and maintaining GMP, GLP and ISO compliant quality systems, and specific expertise in the medical device/software approval processes.
Previously held high level Quality Assurance and Regulatory Affairs roles positions at BD, Philips Medical, and several consulting roles across the med device/biotech industries.
Projects include guidance to medical device clients in support of their goal to comply in all aspects of domestic and international quality and regulatory regulations including FDA (QSR), Medical Device Directive (93/42/EEC) as well as international standards ISO 13485.