PROTEC Industries |
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International Packaging Consultants Protec is an international packaging consulting firm
specializing in the consumer and industrial sectors and active in forensics, regulatory
compliance, technical and business development. |
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Regulatory Compliance Consulting
Protec has assessed operations of medical device firms under regulatory scrutiny and provided development activities to bring the firm into compliance. The firm has regularly managed the needs of firms where regulatory issues must be addressed during development, process engineering, operations and manufacturing.
Regulatory affairs consulting - A wholly owned subsidiary of a Fortune 500 firm had us purchase and install capital equipment and validate their packaging program for compliance in the medical device area. Protec completely revamped their specification program and conducted technical services supporting the incoming Quality Assurance and Control function of all critical packaging components. The firm also had Protec create and implement a vendor qualification and audit program for all raw materials as well as in-house label printing capabilities requiring regulatory compliance. Additional projects are underway involving management consulting. We authored and performed IQ/PQ/OQ validation activities and were responsible for specification revisions and procedures implementation of the documentation processes in purchasing, quality assurance, quality control and manufacturing of class I medical devices.