Services

The services we offer in our key areas of expertise include:



1. project management and other 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

2. hands-on execution of specific quality & regulatory project aspects

3. 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

4. personal coaching of quality & regulatory managers

5. 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

6. providing training and workshops in the above areas of expertise 7. interim quality & regulatory management

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