We will audit your eCTD/CTD Dossier about compliance to current EU regulations and ICH guidelines. Before the audit we will set up the regulatory scope of the audit. During the audit, we will check the correctness and promptness of documentation updates, its (technical) correctness, its completeness vs. applicable regulations. In case of post-authorization changes we will check Dossier life cycle and compliance with the documentation approved.

You will receive a detailed post-audit report, in which we will present information about any gaps or errors in the documentation, along with a suggestion about the method for correcting them.

For the generic/hybrid pharmaceutical product, the audit for will take 8 hours for audit preparation, 8 hours for actual audit and 8 hours for writing of audit report. Altogether we will spend minimum of 24 consultant hours at this job. For the biosimilar or innovative products additional hours may be needed for actual audit.

This offer is valid for Dossier which is available in digital format (pdf, NeeS, eCTD) for on-line for audit. If Dossier should be inspected at the offices of client, then additional expenses for traveling, hotel and daily allowance will apply.