Conducting audits

Registration of medicines and obtaining a registration certificate is impossible without an appropriate clinical trial of proper quality. The proper quality of the study as a whole or its individual components, required by the State Regulator in the field of drug circulation, is confirmed by one or a series of independent audits. Audit is a mandatory part of all clinical trials. The results of the audit must be attached to the general package of documents that are part of the registration dossier.

AX CT LLC provides comprehensive assistance in both clinical trials and independent audits. The work of the auditor is carried out in compliance with the provisions of the rules and requirements of Good Clinical Practice applicable to the study.

"Turnkey" Project

You can provide only the molecule name, and we will develop the entire strategy for bringing the drug to market: from designing, calculating the sample size, selecting a reference drug, its procurement (in the Russian Federation or import), to writing the final report on the conducted research and submitting it to regulatory authorities.

Optimal speed and quality of services

Full compliance with international norms and standards

Logistical availability

Risk reduction and rapid response