Scope and detail of the plan is dictated by the client; it is a living document that evolves along with the project. We adapt our strategy in accordance with changing regulatory requirements via:
- Continuous monitoring of regulatory requirements and adapting the plan to reduce development time and ensure optimal presentation of submission to regulatory authorities.
- Providing customized, strategic response to meet our clients’ goals. Our “learning/confirming” approach to drug development is designed to offer timely, cost-effective and efficient strategies to steer a molecule from discovery to the market.