Primary Contacts

Assign the people responsible for regulatory correspondence, quality leadership, legal review, operations, and medical oversight.

Regulatory lead

Owns regulatory filings, FDA correspondence, and serious adverse event submissions.

Quality lead

Oversees quality systems, inspections, and corrective actions across manufacturing.

Legal counsel

Handles legal review of filings, enforcement actions, and regulator correspondence.

Operations lead

Coordinates recall execution, retailer notifications, and supply chain impact.

Medical reviewer

Provides clinical review for adverse event escalation and submission decisions.

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