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David Chesney
MSJ ·
Cumberland Foreside,, Maine
GMP, GCP, QSR and Pharmacovigilance compliance, both pre and post-marketing
Development of corporate regulatory compliance strategy
Management controls for regulatory compliance
Analysis and development of quality assurance organizations and quality systems
Laboratory controls
Failure and deviation investigations
Investigation and resolution of data integrity issues
Drug safety and compliance with pharmacovigilance requirements
Management of responses to regulatory inspections and enforcement actions
Representation of clients to the FDA and assistance with FDA communications
Training in FDA compliance topics
Law
Medical Devices
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