ABS Clinical & Regulatory Consulting 

Experience:

·       16 years of regulatory, clinical and quality experience with medical devices, drugs and biologic products.

·       Seasoned member of executive staff teams.  Solely responsible for the development and execution of novel clinical and regulatory strategies.

·       Direct experience with:

v    early stage organizations and large pharmaceutical corporations.

v    transitioning from privately held to publicly traded company.

v    developing and executing FDA approval strategies.

v    preparing for and managing FDA inspections.

v    writing submissions including 510(k)s, IDEs, BLAs and European Technical Files.

v    quality system development and deployment.

v    recruiting, building and managing teams of 50+ employees.

v    all aspects of clinical trial development from protocol generation, IRB and EC approval, training, contract negotiation, data management & tissue collection and banking.

Healthcare & Product Areas:

·       Peripheral Arterial Disease

·       Cardiovascular Disease

·       Oncology

·       Women’s healthcare

·       Infectious diseases

·       Cell collection devices

·       Gene expression and immunodiagnostic assays

·       Atherectomy and CTO devices

·       Aesthetic laser devices

·       Early stage CV drug evaluation

·       Life science research