Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.
We will take you all the way through to compliance following a high quality compliance audit.
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In June, FDA released a draft guidance intended to clarify the benefit and risk factors they will consider for medical device compliance and enforcement actions that could impact device availability....Continue Reading
An analysis of Warning Letters and other FDA communications over the past five years reveals a few key mistakes pharmaceutical, medical device and other regulated companies are making time and time...Continue Reading