A Source of Quality and Regulatory Innovation
You are a new start-up company:
Perhaps you are a company that has grown around an invention from a university science department. With the steady expansion of regulatory scrutiny into the earlier part of the development cycle and rising quality expectations, early attention to quality and traceability of your data has become ever more important.
- The design of your invention,
- How you came to prove the concept,
- What modifications you made along the way (to get to the point where you had a physical entity with which you could prove your concept),
- The definition of your product,
- The regulatory pathway which it should it follow,
- The Quality Management System and Standards to which it has to comply,
- How your product is scalable, reproducible and safe,
They are the types of information that have to be transparent to investors and regulatory bodies.
With years of experience in Design/Research and Good Development Practice based on Quality Management System principles we can offer you tailor-made solutions best suited to your setting which you will fully own and control once developed.
Pirus consulting can also help you to:
- Define your product
- Determine the standards to which it has to comply
- Determine its regulatory pathway to market.
- Organise the information so that a potential investor can reach a decision quickly and efficiently in your favour.
- Help you put together any regulatory filing