We assist clients in conforming to FDA Good Manufacturing Practice (GMP) and EU GMP I and II requirements for finished pharmaceuticals and active pharmaceutical ingredients in the U.S. and around the world as well as for assuring that the manufacture of pharmaceutical excipients is consistent with the IPEC-PQG Good Manufacturing Practice guidelines. We assist drug manufacturers worldwide to address observations of poor production or quality control practices made during FDA or EMA GMP inspections, remediating GMP deficiencies, and responding in writing to any communications from these agencies such as Warning Letters issued by the U.S. FDA based on FDA-483 inspectional observations. We are also prepared to assist your firm by taking part in any regulatory meetings with such agencies to achieve positive outcomes for our clients. While our focus is on addressing GMP issues, we can also help your firm with regard to other compliance matters involving new drug, labelling, import/export, as well as registration, listing and global supply chain/quality issues.
How Transnational Strategy Group Can Help
Our Pharma team has worked in key enforcement positions at the FDA’s Center for Drug Evaluation and Research and FDA’s Office of Enforcement and in a consulting role for the private sector. This background offers extensive, hands-on knowledge of and experience with FDA policies. That complements well with our private sector experience in handling pharmaceutical GMP and other U.S. and European compliance matters relating to product quality and other issues.
We are pleased to work with small or novice firms to help them remediate GMP deficiencies so that they can comply with the pharmaceutical GMP and related product quality requirements both in the U.S. and abroad.
Through its worldwide network of Senior Advisors and consultants, TSG can also offer pharmaceutical companies of all sizes other consulting services, such as for international trade and business development, including working with venture capital groups, and in the area of governmental relations.
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