Within our area of expertise we offer specialized GxP consulting on an hourly basis. We can operate in different ways, depending on your needs. Together with our clients we think out of the box to come to the best possible service solution. Some examples:

• Our senior consultants can offer a GxP hotline so that your internal QA staff can reach out to our experts for advice. Think of audit questions, compliance issues, technical advice etc. Services are invoiced on an hourly basis without a strict minimum.
• We help you draft an audit response or remediation plan after a GxP inspection that went not so well.
• We come on site to visit your facility and provide a report with detailed guidance to improve compliance, efficiency, or whatever targets you want to achieve.
• Our consultants perform an assessment of your GxP computer systems to evaluate whether they meet 21CFR Part 11 and Eudralex Annex 11.