Healthcare Compliance

Luminance Health’s Healthcare Compliance support includes advising on the framework for interactions with healthcare professionals (HCPs), healthcare organizations (HCOs) and patient organizations (POs), and preparing documents such as agreements. We not only advise on the framework for promotional activities but also perform cross-functional reviews of promotional materials. In instances where regulatory authorities and/or self-regulation bodies must be involved, we can submit the materials and/or the information to the latter on your behalf. 

The services of the Person Responsible for Advertising in Switzerland are performed on a mandate basis. The statutory role includes reviewing and signing off advertising materials, responding to Swissmedic communications, conducting training and keeping records.

For a smooth review and approval process for activities in the field of healthcare compliance, we support with creating and reviewing subject-specific SOPs. Further support in this area includes performing training and audits.

Advising on the framework

  • Interactions with HCPs, HCOs and POs

  • Promotional activities

  • Events

  • Role of regulatory authorities and self-regulation bodies

Review of materials

  • Advertisements, printed promotional materials and product websites

  • Materials with content of a promotional character

  • Involvement of cross-functional teams

  • Submission to regulatory authorities & self-regulation bodies

Person Responsible for Advertising

  • Signing-off advertising materials

  • Communication with Swissmedic

  • Conducting training

  • Record-keeping

Subject-specific SOPs

  • Creation

  • Review

  • Training

  • Audits