We provide Expert Testimony and Opinions in the fields of manufacturing and qualty testing/assessment of active pharmaceutical ingredients (APIs), biological and biotechnology products, medical devices/equipment and diagnostic products; and pharmaceuticals.

Our specific expertise relates to Good Manufacturing Practice Regulations (GMP), Quality Management Systems, and drug registration requirements.

We are intimately familiar with all aspects of FDA's enforcement activities and have expertise in assisting companies in providing FDA with plans that enable rapid cost-effective recovery from Warning Letter situations.

Our practice is global and we have provided expert testimony in arbitration and courts in Canada, Jordan, Switzerland, the United Kingdom and the United States.