Project management

    project management and hands-on support, e.g. regarding:

    • implementation or upgrading of quality systems
    • software validation and/or process validation projects
    • integration of risk management in your quality system and organization

    Quality & regulatory audits

    • internal audits
    • mock external audits, e.g. notified body or FDA mock audits
    • supplier audits
    • training of auditors and auditors to be


    personal coaching of quality & regulatory managers

    facilitating group sessions, e.g.:

    • risk analyses sessions
    • problem solving sessions (regarding how to execute adequate corrective and preventive actions)
    • strategy development and implementation review sessions
    • management reviews

    Training and workshops

    Providing training and workshops in the above areas of expertise


    interim quality & regulatory management

    All services we offer will be fully customized to your wishes and needs.