Our team of industry veterans has significant regulatory experience and capabilities to assist our clients with respect to assessing GMP quality and regulatory requirements. Our service is very often a GMP Compliance or Mock Inspection. We identify the areas where the current compliance status needs to be improved.
Our audit report summarizes the GAP between the requirements laid down in FDA regulations and Guidance documents and contains recommendations to close the GAP. In addition to this analysis, we can support you with the implementation of the recommendations into practice, e. g. by writing SOP's, Validation Master Plans and other Compliance documents. This includes the consulting service to prepare for an FDA or EU GMP Inspection