Barile and Associates, Inc

medical devices

About

Advisors to the Medical Device, Human Tissue, Pharmaceutical and Biotechnology industries, we complement, enhance and reinforce your team. We are experts in regulatory affairs, quality assurance, compliance, operations, manufacturing, validation, information technology and human resources. We have offices in North America, the Middle East, Asia and Europe. 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.

Technologies

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Keywords

medical equipment manufacturing risk assessment clinical study management process design pharmaceuticals quality assurance consulting regulatory strategy development services risk-based validation international regulatory support product development manufacturing support global regulatory compliance training programs supply chain management validation audit readiness biotech regulatory documentation regulatory submissions compliance software validation risk management regulatory affairs regulatory compliance inspection support b2b quality system development validation services

Location

Clinton, New Jersey, United States, 08809

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