Qualification & Validation
Qualification & Validation
Quality Assurance
Quality Assurance
Regulatory Affairs
Regulatory Affairs
Clinical
Clinical
Lab Services
Lab Services
Vigilance
Vigilance
Software Solutions & Services
Software Solutions & Services
Tox green
Toxicology
Pharma (2)
Pharma & Biotech
Medical Devices (2)
Medical devices
IVD (2)
In vitro diagnostics
Search QbD Group
  • There are no suggestions because the search field is empty.
Artwork & Labeling - Regulatory Affairs - QbD Group

Artwork & Labeling

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 Group’s regulatory experts will help you to create pharmaceutical artwork and pharmaceutical labels for your products in full compliance with current regulations.

Read more

 

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

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

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 (Patient Information Leaflets) and label texts tailored to your needs.

 

Here's how we can help:

Prepare compliant PILs and label texts

Oversee translation projects

Review PILs and label texts for compliance

Provide expert advice on user testing for PILs

portrait image - website (26)

Why partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​ 

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, at QbD Austria with a special focus on Europe (EU) and China.​
  • Customer satisfaction​: constant evaluation, transparency and clear objectives.​ 
Get in touch
doc-mask

Related content

preview_image
Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.
Read more
preview_image
Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!
Read more
preview_image
Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.
Read more
preview_image
Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.
Read more
Discover all

 

contact-mail

Get in touch

Need help with compliant pharmaceutical artwork and labeling?

Our experts are here to assist, ensuring your texts and designs meet all regulatory requirements.  

Fill out the form and we’ll guide you to compliance.














RA_Get in touch