We have worked in your positions. We are familiar with various challenges of today’s industry and a regulated business. Based on our practical experience we know your challenges and we now how to master them, navigating the ship through rough waters, back to calm waters.
We are providing strategic, tactical and hands-on support for your team. Together with our global team experts and partners we do lead the entire program management, taking over roles as project leader or subject matter experts.
Our services range from preparations of FDA and other governmental inspections, support during inspections, response letters, and remediation programs. Our ambitions is helping you to avoid a Warning Letter, Import Detention, Consent Decree or the loss of manufacturing licenses.