BioTech/Drugs - Worcester, MA, US
FOSTERING INNOVATION AND PRODUCT DEVELOPMENT THROUGH AWARENESS AND IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEMS AND TOOLS FOR MEDICAL DEVICE AND MANUFACTURING INDUSTIRESHow do you transition from research to development? - We help you identify and implement the building blocks for robust research and development teams. These building blocks are based on best quality practices and are essential for commercial success.Our goal is to help you build a self-sustaining system that provides growing companies the basis for managing technology transfer and outsourcing/supply chain management activities.We provide services in:Written procedures/standardized reportingIdentification of stage-appropriate metrics for critical business, science, and regulatory needsMeasuring and monitoring business and product metricsRisk assessment and managementQuality manuals and quality management systemsStatistical supportValidation activitiesWe are certified internal/lead auditors serving companies interested in ISO 9001, ISO 13485, ISO 17025 and pharmaceutical GMP.
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