Defining the path towards critical value inflection points and its timely execution while balancing risks and resources is a key strategic focus for small to medium enterprises. Integrating project specific development strategies and the respective milestone deliverables in the overall corporate objectives provides a strategic roadmap to valuable exit points and allows acceleration of high value projects.
At NDA we’ve brought together unmatched scientific and regulatory expertise that provides a unique strategic partnership. We can help you map out the development opportunities, assess the risks, provide risk mitigation and management tools and we can help you determine a clear path forward to the next value inflection point.
By applying a stage-gate approach, we can help you focus on defining input data to inform decision-making at critical stages.
The experts at NDA can provide a “sounding board” for business ideas, a “strategic partner” to help you get from idea to value and an “execution partner” to help you execute projects efficiently within the resource constraints.
The benefits of this approach are:
- Tailored drug development advice to meet the regulatory requirements and expectations for both the EU and the US
- Expert critical input and assessment of alternative routes for product development
- Focus resources, accelerate development, provide choices for exit scenarios
- Increased efficiency due to the identification of common (core) requirements, resulting in a core FIH clinical dossier for the EU and US
The stage-gate approach enables a clear establishment of acceptable product profile and identification of strategies to mitigate any challenges/gaps. In addition, this enables an early assessment of benefit/risk which is further developed through life cycle.