Development and maintenance of product information

Stay compliant with legislations and standards for product information.

Essentials of product information

Regulatory requirements and standards for pharmaceutical product information are defined by the major authorities EMA, FDA etc. 

The MAH is responsible for the central level development and maintenance of the master labelling document, the Company Core Data Sheet (CCDS). Regulatory authorities will rely on the CCDS information for decision making about your products efficacy and safety. The CCDS is the core source of information when creating labels for local markets.

A product’s Summary of Product Characteristics (SmPc) includes information about the following apects of labelling:

Package leaflet


Package product information

Company Core Data Sheet (CCDS)

Why use our support with development of and maintenance of product information?

Our experts will ensure quality in:

  • Timely updates of product information
  • Regulatory compliance
  • Accuracy and completion in product data
  • Usage of the CCDS in product labelling projects
More Labelling services

Labelling expertise and regulatory strategy
Local product information services

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.