Pharmaceutical Artwork and Labels
Pharmaceutical artwork and labels play an important role in the marketing process of any medicinal product. The advertising and labelling texts for prescription and OTC drugs are highly regulated.
QbD’s regulatory experts will help you to create pharmaceutical artwork and pharmaceutical labels for your products in full compliance with current regulations.
Marketing in compliance
Directive 2001/83/EC requires that label texts must be in accordance with the approved Summary of Product Characteristics (SmPC).
For centrally registered products there is only one SmPC, for Mutual Recognition or Decentralised Procedures the SmPCs are harmonized for the countries where the product is registered. In these cases, the label texts are also harmonized in the countries where the product is launched.
For “older” national licences with possibly different SmPC the label texts and Patient information Leaflet may differ from country to country.
Software Requirements
Document Management Software + Change Control Processes:
- Appropriate archiving and electronic document management for packaging materials (repository)
- Revision numbers
- Change Control
- Process flow management
- Versioning
- SOPs
- Provision of XML-based authoring tools
How we support you
- Prepare compliant PILs and labels texts based on SmPCs
- Oversee texts translation projects
- Check PILs and Labels texts for compliance
- Advise on user testing for PILs
Why QbD Group?
Benefit from our team of highly qualified consultants.
Full support from pre- to the post-marketing phase.
QbD Group operates on a global scale, with offices strategically located across Europe and South America. This extensive network allows us to efficiently execute projects in diverse locations worldwide.
Constant evaluation, transparency and clear objectives.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
