Companies in the pharmaceutical industry are validated and meet strict quality specifications. However, there is a considerable compliance risk around the topic of FMD: The suspected cases of counterfeiting that occur again and again in daily operations are not recognised, processed and documented in a GxP-compliant form.
With our free, anonymous and non-binding Compliance Check-up, we analyse and evaluate all critical alerts of your company. To let you know where you stand and how vulnerable you are.
By law (Delegated Regulation § 39), the authorities have the right to see all reports of potential falsification cases. For up to five years. In other words, not a single suspicion of falsification escapes the authorities. Upon request, you must be able to provide information about each individual case: What happened, how was the case handled?
With our cost-free Compliance Check-up, we conduct a comprehensive analysis of GxP compliance based on your existing FMD audit trail:
The analysis takes place entirely within your data system. So you don’t need to disclose any data. Everything remains anonymous.
Yes. We offer our Compliance Check-up to potential clients free of charge. On the one hand, we want to make you aware of potential risks. On the other hand, we would like you to get to know us: medAspis – The FMD Company. We can only do one thing. But that properly. FMD.
We work closely with all NMVOs and know the respective processes in the countries very well. And we are happy to support you in ensuring that FMD functions efficiently and in compliance with GxP.
Cost-free, anonymous and non-binding FMD Compliance Check-up for GxP compliance.