We will begin by reverse engineering the original product. Then, we develop our own prototypes and test them rigorously. To ensure that you have no problems producing it, we will help you optimise the manufacturing process. And, of course, we can do just a part of the whole process, or we can take care of the entire thing, end-to-end.
We have many years of experience with drug product development and more than 100 projects under our belt. We are able to combine our technical skills with specialised analytical equipment and project management skills.
We will help you find the right way to select the API, develop it into a useful dosage form, and fine-tune the manufacturing processes. We can also help with troubleshooting and problem analysis.
API solid form
Full experimental design for API solid form preparation and selection. Starting with small solid-state experiments and going all the way to the physico-chemical characterisation of new crystal or amorphous API forms. We can help you scale up processes to continue on an industrial scale.
Standard and nonstandard experimental testing to fully characterise API. Different angles of API characterisation: in vitro testing, chemical degradation, and solid-state stability. We can also perform evaluations regarding molecular and powder properties.
The typical missing link in drug product development. In case of trouble, we step in and characterise the granules or pellets based on the project needs and identify critical quality attributes.
Understanding the original or competitor’s product and uncovering the issues during drug development transfer or standard manufacturing? We can do it. Need to better understand the differences or similarities between the test and reference before clinical trials? No problem. We have extensive knowledge, experience, and state-of-the-art equipment to be the right partner for you.