Product Development
Product development is an integrative and multidisciplinary process that consists of several activities performed in parallel. It starts with scientific innovation and ends with successful commercialization of the product in order to improve patients’ lives. The process may continue beyond this stage, as second generation products develop.
The product development process consists of 4 main complementary components:
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- Scientific development
- Clinical development
- Regulatory development
- Quality development
We can help you with:
- Comprehensive product development
- Consulting on any of the 4 processes mentioned above
- Specific problem/issue solving
As the product matures, some of these activities become more important, while others decrease. As an example, scientific development constitutes the major activity in the early stages, requiring allocation of most of the resources of a company. However, as clinical development takes over, less innovation is required. Regulatory development should be initiated early in the process in order to enable the developer to accomplish the goal cheaper and faster.
We encourage you to create a Quality Management System not only because it is a mandatory regulatory requirement, but because we think that it will benefit you in the long run. We can help you work within the framework of quality from early stages, without investing significant funds.
In our experience, this entire process should be regarded as a continuum and addressed comprehensively from its infancy. Although differences exist, the general concepts are similar for both therapeutics and medical devices.