Regulatory intelligence is a vital component for successful product development. In order to ensure that current regulatory requirements and future regulatory trends are implemented, access to a source of the most recent developments is essential.
It is essential for creating a competitive advantage, providing insight to help negotiate hurdles and avoid pitfalls, predicting authority requirements at a local level, and anticipating agency questions – all increasing the probability of faster access to market.
SEQ services include:
Advice on the optimum route of submission in the EU Zone, the procedural steps and agency requirements.
Determine the likely position of a product through review of existing or newly-approved competitors, and gather local intelligence on rationales for approval or rejection.
Systematic examination of existing, new and updated regulations/guidelines, their implementation and impact on product development and submission activities.