Regulatory Inspections and cGMP

Representative experience

Advised multiple clients on drug shortage and supply chain disruption due to export bans of certain medicinal products due to the COVID-19 pandemic.

Provided onsite FDA inspection and GMP/data integrity support to manufacturing sites around the world, including in the United States, China, India, Japan, Europe, and South America.

Helped pharmaceutical companies, large and small, around the globe successfully resolve Form FDA 483 observations and Warning Letters.

Conducted privileged investigations of alleged significant GMP compliance and data integrity deviations.

Successfully assisted companies and individual defendants in vacating GMP consent decrees.

Provided regulatory and white-collar investigation support to pharmaceutical companies in responding to qui tam (whistleblower) actions involving GMP and data integrity allegations.

Helped develop and implement GMP policies and procedures and related training.

Developed briefing materials and prepared CEOs and senior executives for “make or break” meetings with FDA.

Successfully counseled numerous foreign manufacturers through the process of lifting GMP Warning Letters and Import Alerts (Import Bans).

Negotiated civil and criminal settlements involving government investigations into GMP violations.

Developed responses and strategies to address drug approval issues and FDA complete response letters related to manufacturing and GMP concerns.

Engaged FDA on averting drug shortages due to manufacturing constraints.

Negotiated many GMP-related consent decrees with FDA, and defend criminal prosecutions of companies and executives under the Park doctrine.