Quality Assurance and Auditing
At INAMED, Quality Management (QM) is an independent unit that cares for the highest quality in GMP, GLP and GCP.
From early study synopsis to final reporting, a process that takes place at our various 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 are in full compliance with regulatory requirements, INAMEDs and/or client's 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 subcontractors
- 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
- Tailor made