Artwork & Labeling
Marketing in compliance
Directive 2001/83/EC requires that label texts must be in accordance with the approved Summary of Product Characteristics. QbD Group helps you create pharmaceutical artwork in full compliance.
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.
How we support you
Accurate, compliant, and user-friendly product information is essential to meet regulatory standards and ensure patient safety. At QbD Group, we assist you in crafting and managing high-quality PILs and label texts tailored to your needs. Here's how we can help:
Prepare compliant PILs and label texts
Creation and review of PILs and label texts aligned with approved SmPCs and regulatory requirements.
Oversee translation projects
Coordination and oversight of translation projects across all required languages for your markets.
Review PILs and label texts for compliance
Thorough review ensuring adherence to Directive 2001/83/EC requirements and SmPC consistency.
Expert advice on user testing for PILs
Specialist guidance on user testing methodologies to ensure patient comprehension and accessibility.
Software requirements
• Revision numbers
• Change Control
• Process flow management
• Versioning
• SOPs
• Provision of XML-based authoring tools
Why QbD Group
Your trusted partner
Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.
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 globally, with QbD Austria having a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.