How do I keep up with rapidly changing regulations?
How can I make sure that with all the changing regulations my landscape of processes and information still makes sense and is ready for the future?
How can I ensure compliance while making the journey from compliance cost to compliance value?
How can I be compliant on one side, but also stay competitive on the other side and not overdo compliance measures?
How do I implement a „Compliance Culture“ in a way that it’s not a burden, but part of my Company DNA?
Solving these and more questions is what we have been doing over the past 10-15 years. We have supported many clients with a broad range of compliance challenges including Regulatory Compliance like IDMP, Supply Chain and Manufacturing compliance topics like Annex16 or Serialisation, and Commercial Compliance such as Sunshine Act/EFPIA Transparency.
With our unique LIVEradar© for compliance, you stay on top of all requirement changes and are prepared for the upcoming changes of the next 5 years, so you can include it in your roadmaps and properly plan for it.
Learn more about some of the things we have done so far:
Gap analysis for IDMP and other regulation changes
IDMP and other regulation changes don’t only mean you need to submit different data to the authority, it will also have a significant impact on your organisation – your people, your processes and your tools. What exactly is needed if the regulation changes? Where are the gaps in todays framework you have? How could a transition plan look like and how do you avoid exaggerating?
Quality and Compliance Culture
Do you think that everyone within your organisation should always be thinking about compliance and quality? What if we could see quality and compliance effort as added value and not as a burden? From our experience, continuous improvement can be constant and not just a once a year exercise. It is possible that people actually value compliance – it is a matter of how you position these topics within your organisation.
Your team doesn’t have much experience with auditors? You are not sure where your gaps are, but want to be prepared for the upcoming audit? Why not have a mock audit performed by us. You get to know your findings in a safe environment before the real audit happens and are well prepared for the challenging questions of the auditors.