The DFE Pharma customised range is not a real product range, but rather a well defined process. It is our way to develop new inhalation lactose products and services specifically for you. This encompasses any of your specifications, demands, production processes or applications that we currently are not able to meet.
The process is designed in such a way that based on mutual agreement and partnership milestones are set and products will become available. When you require a customised grade DFE Pharma will form a dedicated projectteam. At least your sales representative, the productmanager and R&D manager will participate. You can expect exceptionally well trained people with a passion to deliver precisely what is needed to get your product(s) to the market. Our goal is to build a bridge between your application and our capabilities.
Successful customisation steps
The DFE Pharma steps for a successful customisation project are:
1. Initiation phase
During this phase all your specific needs for this customisation project are described and verified with our capabilities. This will already involve extensive communication between our respective departments. We will move to the next phase when we have a joint fit.
2. Development phase
A dedicated project team will initiate small scale development to meet your needs. You will receive development product for your internal evaluation. This phase may include multiple steps to achieve the desired result. After your approval we will move to the upscaling phase.
3. Upscaling phase
The development product is handed over to our Process Development Department for large scale production trials. You will assess if this trial product still meets your requirements. Small adjustments based on your evaluation can still be incorporated in this phase.
4. Validation phase
In this phase, the manufacturing process is validated according to our internal procedures based on cGMP standards. Upon successful completion of our validation and clearance of this product, you can use it for your commercial production.
5. Commercial phase
The new lactose product is embedded in our regular organisation and will be supplied according to the agreed conditions.