Ready for Annex 11
You are a pharmaceutical company or a CRO and want to meet the new requirements of the EU GMP Guide Annex 11? Or do you have to endure a GAP analysis can be due to external quality requirements? Together with you, we examine what you already meet and where actually is a need for action. Usually it is less than it seems. We currently already set this successfully at large pharmaceutical companies, by combining the requirements with existing quality systems and ensure a minimum amount of effort.