Michael Barile Email & Phone Number

Us

Advisors to the Medical Device, Human Tissue, Pharmaceutical and Biotechnology industries, we complement, enhance and reinforce your team. We are experts in quality assurance, compliance, R&D, operations, manufacturing, validation, information technology, regulatory affairs and human resources.Comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the industries we serve. We have a great depth of technical expertise with capabilities in design and manufacturing engineering, science, statistics, quality systems, process design and validation, computer technology deployment and validation. We are experts in US FDA and international regulatory requirements.

EXPERTech was a premier boutique FDA regulatory and quality systems consulting firm focused on the medical device industry. The firm specialized in crisis management and it had clients in the United States and in Europe. It was sold in 2003.

Reporting to the CEO, provide executive direction of the Quality Assurance function for this global$1B leading manufacturer of medical instrumentation, medical devices, pharmaceuticals and human tissue based products with QA/RA responsibility for sixteen manufacturing and distribution facilities worldwide. Member of the senior management team setting strategic business direction