QA Support and Management
Team's track record:
Our auditors are senior professionals with over 300 audits under their belts, ensuring strict compliance and expertise in navigating regulatory requirement.
Our QA team offer comprehensive assistance in setting up Quality Management Systems (QMS) and audit tailored to your specific needs. Through meticulous QMS process definition, precise sizing, and seamless implementation, we ensure the highest standards in our QA activities.
Our scope of work:
Quality Management System definition, sizing, and implementation. We establish Quality Agreements, evaluate compliance of subcontractors, review the project documentation and manage all the quality events (deviation, investigation, change control, out of specifications of any other non-conformity).
Audits
We conduct audits internationally and CAPA following, covering all the supply chain of your product such as:
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Cell Bank Manufacturing and storage
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Biological or non-biological Drug Substance manufacturing and Control
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Sterile or non-sterile Drug Product manufacturing and control
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Clinical labelling and packaging
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Final release of your clinical product
Training
We provide training on the implementation of management and documentation systems to meet clinical sponsor requirements.