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The Expert Respiratory CRO

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Quality Assurance and Auditing

At INAMED the Quality Management (QM) is an independent unit assuring highest quality in GMP, GLP and GCP.

From early study synopsis to final reporting at our different departments (e.g. In vitro investigations, clinical operations, data management, statistics, and medical writing) our QM-System assures that all relevant quality aspects are observed.

Our procedures secure full compliance with regulatory requirements, INAMED and/or client standard operating procedures (SOPs) and ICH Guidelines.

In addition, Inamed offers a variety of services:

GMP, GLP and/or GCP audits:
• at client’s site – e.g. system audits, trial audits
• of sub-contractors
• Investigational sites
• Certification of audit

QA consulting and support of clients to build up their own system:
• Quality system development
• SOP design, development and implementation

GMP. GLP and GCP training:
• at client’s site – staff and CRAs
• Investigators and study nurses
• Taylor made

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