However much improved life sciences firms are in their approach to regulatory information management, labelling continues to buck the trend. Siloed systems and an over-reliance on manual checks continue to incur risk, delay and cost, especially across international operations. In this article, Amplexor senior life sciences consultant Agnes Cwienczek advises on an alternative way forward.
Way forward
Labelling management is increasingly becoming a point of pain that life sciences companies cannot ease with existing approaches. Failure to respond quickly to changing product information or market requirements can result in delays to market, or rejected product registrations, with an impact on sales, revenues and market profile.
A major sticking point is the way content interdependencies are managed– i.e. how a change anywhere along the safety-regulatory-manufacturing-supply chain continuum will affect all label content, from the global ‘core data sheet’, to patient-facing product information in each country.