The ‘Single Place of Truth’: Effective regulatory information management for Generics

Abstract

Compared to the active ingredient manufacturers, Generics face different challenges in today’s healthcare market. Smaller margins on products, extensive competition and harsh timelines all play a role in making enough profits to benefit all parties concerned, from the Generics providing the medication via the healthcare professional to the patients. And that is exactly where modern technology can help, specifically considering the ‘Single Place of Truth’. Multinational corporations spend hundreds of thousands in specialised technology covering all angles of the medicinal product life cycle, from drug discovery via marketing applications to drug safety. Furthermore, additional investment is required to integrate these applications to enable the detailed, up to date reporting on consistent accurate data that is vital to understand the dynamics of the healthcare market. Generics with equal requirements in terms of regulatory compliance are facing the same challenges but on far smaller budgets. This article gives an overview on how Generics could benefit from an alternative via the ‘Single Place of Truth’.