Our development experts will work to make your product a reality, starting from the very earliest stages of product conception. We provide screening services, where a time- and cost-effective evaluation of potential formulations can be performed. Our approach is to use computational modeling to inform formulation development to accelerate the subsequent experimental development, which is ultimately required to demonstrate proof of technical feasibility. This means that you save both time and money by doing things more efficiently and sometimes by avoiding extensive work on formulation options that can be ruled out before even entering the laboratory.
After positive feasibility, we can start with further developing your product, taking the guidance of regulatory authorities regarding pharmaceutical product development (e.g., Q8 (R2) Pharmaceutical Development) and design procedures around drug-device-combination products into account. Risk management in the form of process and formulation FMEAs are implemented as part of our development procedures, which facilitates addressing the highest risks early in the development process. Furthermore, we work with you to establish a Quality Target Product Profile (QTPP), which is a regulatory requirement and an important tool for ensuring that we are fully aligned on the product attributes.
With our strong history in commercial manufacture, we are aware of issues that may arise during up-scaling. For this reason, we formulate the product and design the manufacturing process with the potential for large-scale manufacturing in mind, which is critical for avoiding unnecessary late-stage or post-approval changes. Our expertise in polymer-based drug delivery systems and drug-device combination products is truly unique. Explicit guidance on many aspects of the development process of these novel dosage forms is largely lacking. Moreover, using non-compendial release-controlling excipients such as thermoplastic polymers results in scientific, regulatory, and sourcing complexity. The involvement of our experts, with an extensive demonstrated background in this field, will help to ensure that your development proceeds as quickly as possible.
You will receive regular reports on the work being conducted during feasibility and early-stage development. You will also be involved in evaluating data and planning the next steps through frequent team meetings. We believe that good communication with our customers is the key to success, and we will always update you on progress in a clear and timely manner. Our proficiency in project management means that you can be assured of a well-planned and time-efficient approach to developing your product, which results in high cost-efficiency for you and the shortest possible time to the clinic.
