Because the pharmaceutical and Medical Device industries are highly regulated audits are performed to ensure compliance with the regulations and in-house procedures. PharmaRelations can support you in your audits, internal audits as well as mock inspections as preparation for an authority inspection. We have highly skilled and experienced auditors within GxP, PV, as well as ISO 13485 and MDR/IVDR in the Medical Device area.
We ensure the implementation of robust audit processes for Marketing Authorization Holders (MAH).
Our consultants have many years as pharmaceutical inspectors at the Medical Products Agency (Läkemedelsverket), and can help you meet the legal requirements, but also provide practical tips, and solutions to the common issues seen at PV inspections and audits.
It is hard to know where to start when it comes to keeping up with the rapid changes in the life science industry. Our learning services can start by mapping the skills your team has and building a training plan that can help you transform your business,
In addition, PharmaRelations offers an assessment of your commercial practices to help you understand how your channels can help you build for the future.
