“I'm always thinking about creating” – Miles Davis
When should Medical Affairs get involved in clinical development? We believe that the earlier, the better. Medical Affairs can provide valuable insights on the unmet need and begin to plan an aligned medical strategy to give a launch the best chance of success.
However, you need a robust drug development strategy in order to ensure regulatory approval. We partner with a full-service pharmaceutical development provider supporting biotech and pharmaceutical companies throughout all phases of the drug development and marketing process for global markets.
With the goal of ultimately obtaining market approvals in target regions, the team, collaboratively builds the development strategy including timelines and budgets, obtaining regulatory agency advisement on the strategy, and execution of the development programme with complete project management and accountability to the client and stakeholders.
Let’s discuss how we may be able to help your team with their drug development strategy.
Examples of what we may be able to help with:
Execution of the clinical development programme through pre-clinical to market approvals
Strategic regulatory advisement
Post-approval support, including studies to support label updates, chemistry manufacturing controls (CMC) changes