With relevant experience in preparing audits to be conducted both by European authorities and FDA, at Protea we can help you making sure that nothing gets forgotten.
We can review technical development reports and GMP related documentation related to your drug product. We can help you manage all the activities needed prior to an audit to make sure that the documentation you have available is complete and compliant.
We can also assist with finding solutions for closing existing gaps and put together a comprehensive audit checklist.
