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Following receipt of an FDA Warning Letter, a global cardiovascular medical device manufacturer engaged Oxford to support a remediation effort. Our client’s large-scale production operation in Germany urgently needed support to remediate technical documentation, processes, and systems in order to pass the FDA re-inspection and remove the warning letter status.
We supplied 16 senior-level consultants over a two-year period. They were integrated into a classic remediation and warning letter environment that included an internal remediation task force and consultants from multiple agencies. Our consultants worked on several work streams, including:
While our client continued to strive towards FDA compliance, Oxford consultants played vital roles in leading and executing compliance programs that were essential to our client’s European business. The company selected Oxford as a preferred supplier based on a proven ability to deliver skilled consultants into a very challenging and fast-paced environment at short notice.