Saltbox Consulting advises pharmaceutical manufacturers on FDA matters related to approval, marketing, labeling, and safety reporting. Subject matter expertise includes Good Clinical Practices, Good Manufacturing Practices, Good Laboratory Practices, drug compounding requirements, PDUFA applications, off-label marketing rules, anti-kickback rules, FCPA restrictions, and new drug approval requirements.
Representative clients include multinational pharmaceutical companies, biotech start-ups, private equity firms, and venture capital firms.
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