Good Manufacturing Practice
Our group has extensive experience with Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) matters. Our experience extends to a wide variety of products:
- Ingestible
- Capsules
- Liquids
- Ointments and Pastes
- Vaccines
- Plasma
- Biologics
- Medical Devices
- In Vitro Diagnostics
Given the risk-based emphasis of FDA and other government regulatory authorities, our lawyers regularly counsel clients on aseptically manufactured products.
We also work with companies on important reporting requirements. We help to develop Quality and Regulatory reporting systems that comply with necessary obligations relative to such matters as product applications and submissions, post-marketing surveillance and inspection observation responses. When necessary, we also suggest corrective actions, such as recalls.
Compliance with reporting requirements is critical. Failure to comply with these requirements can create significant exposure for companies in regulatory enforcement proceedings, whistleblower cases, corporate and individual criminal prosecutions and accompanying litigation, such as products liability and securities cases.
We have worked with manufacturing sites in a number of countries:
- Austria
- Australia
- Belgium
- Canada
- England
- France
- Germany
- Ireland
- Italy
- Sweden
- Switzerland
- United States
Our offices throughout the world allow us to promptly respond to government inspections and enforcement actions and to coordinate company action plans and communications with worldwide regulatory authorities and the press.
We have represented numerous clients with problematic regulatory histories. We work closely with the manufacturing sites and cooperate with FDA in developing GMP and QSR workplans to execute corrective and preventative actions. In the event that enforcement activities or litigation ensues, we handle that as well.
We provide the following legal support to companies:
- responding to government warning or regulatory letters;
- responding to government inspection reports;
- developing GMP and QSR work plans;
- conducting complex discrepancy, non-conforming product, CAPA and product impact investigations;
- conducting data integrity and documentation practices investigations;
- auditing GMP and QSR system compliance, including post-marketing surveillance systems; and
- training on GMP and QSR systems.