Our lawyers are very experienced with Good Manufacturing Practice (GMP) and Quality System Regulation (QSR) matters. Given the risk-based enforcement strategy of FDA and other regulatory authorities, we regularly counsel clients on a wide variety of aseptically manufactured products, including biological products and medical devices, as well as dietary supplements and functional foods.
From developing compliance systems and work plans to defending clients in complex criminal and civil cases, we help clients at all stages. Our experienced group of lawyers provides legal support to assist companies to do the following:
- Develop GMP and QSR work plans
- Develop quality and regulatory reporting systems in connection with product applications and submissions, post-marketing surveillance and inspection observation responses
- Conduct trainings on GMP and QSR best practice Audit GMP and QSR system compliance, including post-marketing surveillance systems
- Conduct complex discrepancy, non-conforming product, CAPA and product impact investigations
- Conduct data integrity and documentation practices investigations
- Advise on exit interview strategies
- Through interviews and system-based approach help get to root causes
- Suggest corrective actions
- Strategize on responses to FDA 483 reports and warning letters
- Assist in assuring adequate investigation
- Interface with FDA/foreign agencies on series of compliance commitments
- Help avert plants shutting down through rigorous audits
- Coordinate international approaches to manufacturing problems
We have worked with manufacturing sites in a number of countries:
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.