Feasibility / early development
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 an evaluation of potential formulations can be performed in a time- and cost-effective manner. Our approach is to use computer-aided tools to evaluate potential formulation options and then perform short-term studies on the most promising candidates to obtain experimental proof of technical feasibility. This means that you save both time and money by avoiding extensive work on formulation options that can be ruled out before even entering the laboratory.
Data generated during the feasibility stage is used to inform the next stage of development. We will work to develop a product that meets your requirements in line with regulatory guidance on pharmaceutical product development (e.g. Q8 (R2) Pharmaceutical Development). Establishing a quality target product profile (QTPP) early on ensures that we are constantly focused on developing a quality product with acceptable critical quality attributes (CQAs). Risk assessments form an integral part of this process and help to ensure that we address critical risks early in the product life cycle.
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, the use of 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 both feasibility and early-stage development work. You will also be involved in evaluating data and planning the next steps through frequent team meetings. We believe that good communication with our customer is the key to success and 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 the development of your product, which results in high cost-efficiency for you and the shortest possible time to clinic.