Manufacturing & Quality

Keeping your products on the market depends on your ability to demonstrate to FDA that you manufacture your product according to the current good manufacturing practice (“cGMP”) standards for your product and your ability to address FDA inspectional findings in a complete, thorough, and robust manner.  This is no small task.

Our firm’s attorneys have spent years working with companies preparing for and responding to FDA manufacturing inspections and audits.  We bring a practical and pragmatic approach to product manufacturing so that compliance with cGMPs can work seamlessly with your business’ ability to innovate and bring high quality products to market in a financially viable way.

Specifically, our attorneys can help you:

• Draft and negotiate Quality Agreements between you and your partners
• Assess the manufacturing quality compliance status of a potential acquisition
• Support internal audits of your facilities, processes, and procedures
• Prepare your management and staff for an FDA inspection
• Support your team during an FDA inspection
• Respond to FDA inspectional observations
• Design, implement, and communicate with FDA regarding remediation plans, including corrective and preventive action plans
• Defend your company in the event of a Warning Letter, Import Alert, or other FDA enforcement action
• Assist with developing elements of your quality system
• Conduct internal investigations if issues arise that require an independent look