We look for the best audit organization, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.
Once the audit is contracted by the audit sponsors, we initiate our process, setting up the audit days – according the auditee schedule and sponsors’ deadlines. Once the audit is arranged, we look for the best qualified auditor team a Qualified auditors to best address the audit.
We take care of the entire audit lifecycle: audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list.
All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors through the personalized reports.
Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.
EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.
Each sponsor receive a complete report with the information related to the products of their interest and the inclusion of the revision of their specific requirements.
With local auditors all around the globe, we can perform and deliver audits to any country.
API, Medical Devices, Distributors, GCPs, Packaging, Excipients, Carrier and Software
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.