Our teams enable you to address challenges in quality issues across the GXP platform -GCP, GLP, cGMP – in manufacturing, risk assessment, validation, Standard Operating Procedure preparation and review, labelling, facility design review, training, investigations, corrective and preventive actions and provide in-house QA support, where relevant. We can verify compliance of your current quality and compliance plans to your organizational requirements. Assist in preparing for Regulatory Inspections by providing necessary guidance, assessment, training, walkthroughs, mock inspections having spear headed the successful completion of Pre-Approval Inspections (PAI) and BIMO inspections in the USA, Europe and India to include cGMP, GLP and GCP compliance by the team.