Artwork and labelling

Artwork and labelling play an important role in the marketing process of any pharmaceutical. The advertising and labelling texts for prescription and OTC drugs are highly regulated. 

QbDs regulatory experts will help you to create artwork and labellingfor 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

Why QbD Group?

10+ years of experience

Benefit from our team of highly qualified consultants. ​

Full life cycle support

Full support from pre- to the post-marketing phase.​

Global presence​

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.

Customer satisfaction​

Constant evaluation, transparency and clear objectives.​

Contact us


Contact us for more information or to request a free, no-obligation proposal.

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.