The TCG team has a proven track record of helping companies successfully navigate through regulatory enforcement actions with successful outcomes.
We provide remediation communication updates to the FDA in support of the following:
TCG has extensive experience in serving as a third party expert providing responses to Data Integrity Warning Letters. The FDA has increasingly recommended that companies obtain help from qualified third party consulting firms. TCG has been retained to provide this support for numerous clients as a recognized third party Data Integrity expert.
Our approach to addressing remediation is to provide holistic responses along with corrective and preventive actions to address regulatory inspection observations. We have a pragmatic and proven method for developing corrective action plans and building cross functional teams composed of TCG and client SMEs to implement sustainable solutions that are owned by the client. We incorporate coaching and mentoring into remediation efforts which allows our client to benefit from our years of experience and wide breadth of knowledge. Throughout the process we provide regulators with scheduled updates to provide visibility on the remediation efforts; thus builds trust and demonstrates the client’s commitment to achieve compliance with the agency. From start to finish we work in a collaborative manner with clients to achieve a common goal.
TCG has served as a recognized third party expert for FDA verification activities. Third party oversight has been used to provide an independent verification of batches prior to being released. As well as third party independent review to verify data in ANDAs, NDAs, 510(k)s as well as other regulatory submissions.
TCG has aided clients by providing strategic consulting to address complex regulatory situations. We work with Senior Leadership to formulate a strategy that evaluates potential options along with the likely outcomes to provide a robust action plan. As appropriate, we will attend FDA meetings with clients to represent the nature of consultative support and plans for oversight, verification activities and/or remediation support.