Labelling
Development and maintenance of product information
Stay compliant with legislations and standards for product information.
Stay compliant with legislations and standards for 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
Artwork
Package product information
Company Core Data Sheet (CCDS)
Our experts will ensure quality in:
Labelling expertise and regulatory strategy
Local product information services
Erik Hedner
Arex Advisor AB
Contact us
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.