Late development / approval

Approval of your product is our common goal. We know what it takes to get there and have this goal in mind from the earliest stages of development. This makes the transition from earlier development to late development as smooth as possible for products that we have been involved with from the start. We can also work towards a seamless tech transfer of your product from another site and ensure that further development and manufacture is conducted according to your needs. Our experience includes the supply of batches for late phase clinical trials, process validation, and the manufacture of registration batches. Following approval of the product, we can take the step to commercial manufacture together. With our strong history of successful inspections by regulatory authorities from across the globe, including the FDA, you can be assured that you will have a partner that understands the quality requirements on your product.

As in earlier stages of development, we work according to relevant regulatory guidelines and follow principles such as Quality by Design and Design Control for pharmaceutical products and devices, respectively. We are also highly experienced in the development of combination products and can help you to navigate this regulatory pathway, providing relevant supporting documentation for your submission. A key part of the later development of any pharmaceutical product is establishing a design space, whereby the influence of critical material attributes and process parameters on the final product is thoroughly understood and we can demonstrate that your product is manufactured to the highest quality. This knowledge is generated through applying a Design of Experiments (DOE) approach to our development trials, to give you maximum information with minimal effort. By continuing to partner with us in commercial manufacture, you can be assured that this knowledge will follow your product through to production, resulting in the consistent manufacture of a quality product using a robust process.