Our compliance and consulting team has carried out many audits and brings to the table a wealth of knowledge and hands-on experience in GMP and GxP compliance.

Our PIC/S format GMP audits include a GAP analysis of your quality management system, engineering, qualification/validation and operational compliance. Our audit reports include a database of findings complemented by suggestions for resolutions as well as a room-by-room GMP compliance risk assessment for each facility.

We have extensive experience in compliance and GMP as well as a range of local and international regulatory standards.

We have detailed knowledge and understanding of US FDA, ICH, PIC/S and ISO standards as a result of our experience as production/QA personnel or as auditors working within production and QC/QA environments.

 

Commissioning & Validation Engineering

Our validation engineers are proven and reliable partners in conducting qualification and validation studies.

We specialize in the harmonization of Q&V activities, QMS implementation, the commissioning and qualification of pharmaceutical production equipment, sterilizers, clean utilities, clean rooms and laboratory methods.

Training

Eagle Group is your partner to deliver the knowledge and task-based training modules required for PIC/S and cGMP compliance. Furthermore, we organize and run our own cGMP conferences and provide individual training programs for all aspects of your quality management system.

 

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We will allocate a capable and committed team for all your compliance needs.