We have expertise to help you with the preparation of regulatory inspection and to answer to the gaps raised by the inspector.

Our strategic audit process together with a large experience provides the perfect combination to ensure the compliance with:

• The quality system of the company,
• Clinical trial protocols and regulations.

More and more regulators demand to the industry a proper oversight of the trials. In this line we can provide a large range of services to prevent and early detect misconducts that might have an impact on the patient’s rights and data integrity. We have experience in performing quality monitoring visits, definition of risk-based monitoring plans, follow up of monitoring issues and CAPA definition and resolution.

As an essential part of the pharmaceutical industry, we can help you to set up and improve your QM system. We can review and provide strategic advice on the quality manual, policies, SOPs and forms.

Quaity controls (QCs) are essential in the develpment of clinical trials documents. We can support you to set up a list of QCs or execute them. A few examples: review of monitoring reports, metrics, EDC data review, technical documents (ICF, Protocols, Study Reports…).