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Our international team of qualified experts is available for all your needs related to qualification and validation. We are preferred supplier for GxP regulated customers by worldwide everywhere on the website. Our services range from hands-on support to the development or improvement of the qualification and validation approach. Methodologies include GAMP 5, ASTM E2500 and agile validation
Our certified auditors perform internal and external audits based on applicable international GxP standards. To prepare for governmental inspections, our auditors can perform a mock audit. We can perform assessments of existing quality management processes to determine their maturity and identify potential efficiency improvements.
Our GxP Consultants support in establishing the required quality management processes, including design of quality management policies, procedures and work instructions. Furthermore, we train personnel in the application of the quality management system. Our consultants assess existing quality management systems and support with efficiency and maturity improvements. We also supply interim personnel to support quality operations, including quality officers, CAPA investigators, quality engineers, etc.
Upcoming FDA inspection? Our GxP consultants support in preparing for inspections by performing assessments of existing processes and performing any required improvements. A CAPA Plan is designed to define and monitor the improvements actions. Our consultants can support during the actual inspection and help with the remediation of any observations.

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