mARKETING quality

Your marketing quality management in good hands

Quality that saves lives

Pharmaceutical marketing is heavily regulated and that is right because it is about people’s health. A breach of regulations can have far-reaching consequences –

Risk to human health due to misinformation
Loss of approval due to, e.g. off-label advertising
Loss of company image
Risk of fines & imprisonment
Risk of claims for compensation
Risk of warnings, which in the event of recurrence are also associated with high fines

Learning from mistakes

To meet these requirements, many companies standardize their marketing approval processes with software such as Veeva Vault.

However, these systems quickly become data graveyards if they are not used across teams and regular reviews are not carried out.

Despite defined processes, mistakes can happen –

- Due to ignorance of risks
- Due to ignorance of processes
- Through human error

And mistakes are important: only through them can an organization learn and constantly improve. It is therefore crucial to success that mistakes are recognized, communicated transparently and that the lessons learned are shared within the team.

One process solution is Corrective and Preventive Action Management (CAPA). And this is where we at NiSiPharm come in.

Consulting & basics

NiSiPharm supports the development of a marketing quality management (e.g. through implementation of regular audits or review processes) and development of an active CAPA management.

Release

NiSiPharm coordinates approval processes in Veeva Vault: through professional uploading, coordination of approval or even pre-medical review of materials – this makes the approval processes in the company compliant and more efficient – and we create more freedom for employees.