Can you prepare us for an inspection by the authorities?

By Strategic Area

Quality Services

For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions that need to ensure the compliance and quality of their clinical studies, from study design through close-out and archiving.

Quality is not a final check, but a framework we build with you from the study design stage onward, to reduce the risk of non-compliance and protect the integrity of the data you will submit to regulatory authorities. Our Quality Management System for the conduct of clinical studies is ISO 9001:2015 certified (RINA, No. 45381/24/S).

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Quality plan and SOPs

We draft the study quality plan and develop or adapt the sponsor’s standard operating procedures (SOPs), aligned with ICH GCP and, for medical devices, with ISO 14155.

Audits and inspections

We conduct audits of the study’s sites, processes and vendors and prepare you for inspections by the authorities, with support during the inspection as well.

Non-conformities and CAPA

We identify deviations from the protocol and SOPs and manage the corrective and preventive actions (CAPA) needed to close them, with full traceability.

Risk management (RBQM)

We identify the factors critical to quality for each study and build the risk management plan that guides monitoring and controls.

Vendor qualification

We qualify and oversee the study’s vendors (laboratories, couriers, technology providers) so that they work in accordance with GCP.