Protocol Link, Inc. Information

Protocol Link, Inc. is a global project management firm organized to provide comprehensive consulting services for FDA-regulated companies. Since 1996, Protocol Link has offered the best of both quality and efficiency to each one of its clients throughout the United States and 27 countries worldwide. This has been proven by successfully completing over 1,000 projects, utilizing our core staff of Subject Matter Experts. These projects covered areas of discipline including compliance management, quality systems, regulatory affairs and validation and advised firms ranging from start-ups to several multi-national companies. Our team of Subject Matter Experts are dedicated to each and every project. Throughout our 27-year tenure, our SMEs have delivered an array of services, a few of which includes conducting Mock FDA Inspections, Quality Systems action plans and Quality Master Plans, full lifecycle product recall management, cGMP compliance gap analyses, Laboratory Operations and Management, OOS analysis and resolution, change control administration across all production areas, regulatory affairs management, eCTD publishing, submission life cycle management, CDER, CBER and District Liaison, product recall management, championed process validation policies and procedures which encompassed the entire validation lifecycle, test protocols and various IT guidances, and root cause analysis. We not only supply the subject matter expertise required to fulfill project goals in this rapidly expanding and evolving industry, we also bring the Project Management expertise to efficiently direct and complete project tasks on time, every time, the first time. For more information on Careers visit our webpage, www.protocollink.com, and submit your Application under "Contact Us".