Management Consulting - N/A, N/A, N/A
Senior ISO and FDA Quality Management Systems Consultant
Ticalion Quality Management Services, LLC is an experienced and trusted consulting services company that specializes in ISO 9001:2015 and FDA compliant Quality Management System deployment and process improvement for sponsor companies and intermediaries engaged in biopharmaceutical, biologic and medical device product development, manufacturing, and clinical trials.Clients nationwide count on Ticalion for the following expertise: - Quality System Design, Implementation & Remediation for FDA and Global Regulatory Compliance and ISO Registration - Business Process Improvement - Quality Audits - Computerized System Validation - FDA Enforcement Action Responses If your company needs a standardized and compliant quality management system, or is at risk for FDA enforcement action (483's, consent decree and application integrity process), we can help From large- to small-scale projects, our experienced consultants specialize in the development of compliant and value-driven quality systems
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