Why should you choose Sever Pharma Solutions as your preferred development partner?
One answer to this question is our long-standing experience in the technologically demanding area of polymer-based delivery systems. In this area, experience makes the difference for the following reasons:
- explicit dosage form-related regulatory guidance is lacking;
- selection and sourcing of polymeric excipients is an expertise in itself;
- interactions between polymer and drug substance, etc. may be complex.
Another answer can be found in our unique (co)-extrusion capabilities, our readiness to manufacture investigational medicinal products for clinical trials, and our ability to handle drugs in the highest occupational exposure bands.
It is our philosophy to be a transparent and flexible development partner, willing to step in at any point of the development process to serve your objectives. This means that collaboration can start with feasibility screening, followed by all other necessary development steps until the product is ready for commercial production. Collaboration can also be narrower in scope and for example only entail a quick and efficient technology transfer followed by manufacturing in our commercial plant.
As an industrial partner, we are aware of the difficulties related to up-scaling and large-scale manufacturing. For this reason, we always have the end-goal in mind and anticipate large-scale manufacturability throughout product and process design.
Our approach in the different phases of development and the application of design controls, a necessity in relation to the development of drug-device combination products, is further elaborated below. You can navigate to the content by using the hyperlinks listed.