The Belony Group provides a complete suite of regulatory and quality solutions designed to make our client’s business simple and successful. Founded in 2008, we strive to be a single source provider of solutions to the pharmaceutical, dietary supplement, medical device and related industries.
We have experienced staff¬ from the pharmaceutical Medical Device and Dietary Supplement Industries. Our team boasts experience in manufacturing, Quality Systems Compliance and Validation. Our senior staff¬ has over 45 years combined industry experience. Key personnel include former head of quality for the third largest soft gel nutritional supplement firm in the United States, Semi-solid CRO/CMO firms as well as Biotechnology firms. Our corporate staff¬ has successfully developed business processes and quality management systems designed to ensure consistency of quality standards, promote synergy and provide clear picture of challenges to our clients.
We have routinely hosted regulatory agency as well as client audits and spear headed remediation procedures to bring a firm’s compliance standards to appropriate GMP level whether it is to pharmaceutical drug, or dietary supplement standards. Our experience includes, Regulatory Affairs, Quality Assurance, Technical Affairs, Validation and Production. Your Quality System is the most far reaching of all your business processes. It is the system on which you are most often scrutinized to determine the health and viability of your company. Our firm is poised to help you establish and maintain a healthy Quality System and provide expert guidance to make key decisions.
We are knowledgeable with semi-solids as well as hard and soft oral dosage forms. Our firm has conducted raw material vendor and contract laboratory Quality system audits for key industry clients. We have developed and implemented validation of cleaning, process, utilities and equipment to help the firms meet their FDA regulatory requirements. Moreover, the group has developed procedures for compliant documentation systems, calibration, maintenance programs as well as vendor qualification. We view our approach to project management as one of the cornerstones of our success. Our Clients have consistently attributed the great success of their projects to the comprehensive and result-oriented project management philosophy that we bring to the table
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