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Development and Regulatory Strategy

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 and anticipating authority questions – all increasing the probability of faster access to market.

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 objections
    • Systematic examination of existing, new and updated regulations/guidelines, their implementation and impact on product development and submission activities.
    • Advice and support during the interactions with the Regulatory Authorities

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On demand regulatory team an Assion case study

A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.