Compliance and Regulatory Framework
Building a Path to Sustainable Growth
Compliance is often associated with regulation and standardization, perceived as the rule-driven aspect of business. However, we find it more productive to view compliance as a series of developmental stages. At CO-AX, we guide you through four key stages: Orientate, Structure, Execute, and Grow. This framework allows you to align compliance with your business development strategy, adapting it to your way of working.
Orientate, Structure, Execute, and Grow.
1. Orientate
This stage begins with a problem or idea and concludes with an assessment and decision to invest time and resources into pursuing a solution or realizing the idea. Key questions to consider include:
• What are the unique benefits of our product or solution?
• What are the market-specific acceptance criteria?
• Which regulations and standards should guide development to ensure quality and acceptance?
2. Structure
Following the decision made in the orientation phase, this stage involves structuring your approach. It ends with a further decision to continue business development. Critical questions at this stage are:
• What network of processes will form the foundation of our Quality Management System (QMS)?
• What technical documentation is required for regulatory approval?
• What will be our Regulatory Pathway and Plan?
3. Execute
Execution begins when structural components are sufficiently clear. While some elements become clearer during this phase, the foundation set in the first two stages ensures a proactive and action-oriented approach. We adapt and refine as needed, drawing from ongoing learning and experience.
4. Grow
Growth emerges from the continuous feedback cycles and experiences gained during execution. It’s about applying, learning, and adapting in an iterative process. The focus here is on results, impact, and how they are achieved. We blend insights from all four stages and refine the QMS as we mature our approach, fostering sustainable business development.
