Exemplar Compliance

medical devices

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.

Technologies

Gmail Google Apps Gravity Forms WordPress.org Google Tag Manager Mobile Friendly Google Font API IoT Remote AI

Keywords

medical devices quality system development fmea risk management fda response & remediation laboratory quality clinical quality pharmaceuticals compliance pai regulatory medtech gmp quality auditing project management quality system training supplier audits heathtech validation medical equipment manufacturing risk mitigation strategies life sciences in vitro diagnostic quality manufacturing process validation manufacturing compliance mock inspections vigilance reporting capa management fda warning letter response healthcare testing laboratories and services

Location

San Francisco, California, United States

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