Exemplar Compliance Logo - medical devices

Exemplar Compliance

medical devices
China's Best One-Stop Medical Equipment Provider
About

Exemplar is a global consulting firm for pharmaceutical, biopharmaceutical, medical device, MedTech, combination product, IVD and life science companies. We provide best in class support through all phases of the product life-cycle including: pre-commercial, clinical quality, manufacturing, tech transfer, company integration, regulatory submissions, and remediation activities. We provide quality consulting services in the United States, Europe, Asia and around the globe. Our team consists of former FDA Inspectors, Engineers, Quality System Experts, Compliance Professionals, Project Managers, Trainers, and Clinical Quality Specialists. We have extensive expertise in FDA 483 Response, Warning Letter Response & Remediation, Import Alerts, Inspection Readiness Training, Quality Management Systems (QMS), Manufacturing Investigations/CAPA, Internal Auditing, Clinical Quality & GLP, Global Supply Chain Management, Regulatory, Validation, Sterilization, Laboratory and Project Management. *USA, Canada, Europe, Brazil, Puerto Rico, Australia, Japan, China, Taiwan, Korea, Ireland, Israel, India* We love meeting new people. Give us a call and let's talk about your project.

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Keywords
medical devicesquality system developmentfmea risk managementfda response & remediationlaboratory qualityclinical qualitypharmaceuticalscompliancepairegulatorymedtechgmpquality auditingproject managementquality system trainingsupplier auditsheathtechvalidationmedical equipment manufacturingrisk mitigation strategieslife sciencesin vitro diagnostic qualitymanufacturing process validationmanufacturing compliancemock inspectionsvigilance reportingcapa managementfda warning letter responsehealthcaretesting laboratories and services
Company Information
  • Employees11
  • Founded2011
Location

San Francisco, California, United States

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