Fertin Pharma has expert competencies within all areas of product development, making a complicated development and registration process very straightforward for our partners.
We believe that a close relationship with our partners is essential in order to develop products that will satisfy their requirements. We establish this relationship by assigning a core team of dedicated scientists who develop products according to specified requirements. The core team will be responsible for the project from development to product launch on the market.
Our development projects follow a strict stage gate process built on Quality by Design principles in accordance with ICH guidelines. This ensures high product quality, optimal efficacy and regulatory compliance
The key steps involved in this process include:
- Sensory testing
- Dissolution testing
- Bioequivalence testing
- Stability studies in accordance with ICH guidelines
- Development and validation of analytical methods
- Full scale testing
In addition we also provide full clinical and regulatory support including the establishment of Module 3 and CMC documentation.
Fertin Pharma has a state-of-the-art product development lab with a GMP production line for both compressed and extruded chewing gum. These GMP production lines are available e.g. for production of samples for early stage clinical trials (proof of concept), keeping costs down and accelerating the project.