Exemplar Compliance

Exemplar is a global consulting firm for pharmaceutical, biopharmaceutical, medical device, 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.

Company’s Keywords:

pharmaceuticals, medical devices, quality auditing, fda response & remediation, quality system development, quality system training, laboratory quality, gmp, fmea, risk management, supplier audits, clinical quality, compliance, project management, pai