Development and Regulatory Strategy
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:
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- 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
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.