On your behalf
Oncotec develops and produces sterile cytostatics for you - as contract work. Our strength is flexibility when doing so. During the product development and during the regular contract manufacturing, we offer you fast constructive proposals for solutions of high quality. These proposals for solutions are worked out in close co-operation with the customer in compliance with product specifications, individual customer needs and a fast feasibility.
Based on a jointly agreed project plan, the realization of the project is done for the customer in a transparent way.
The good relation between the customer and Oncotec is based on the philosophy of „one-face-to-the-customer“. This fast communication channel contributes significantly to the success of the project.
Important success parameters are a convincing cost-benefit ratio as well as a „time to market“-strategy, which has been agreed on with the customer.
Our development program covers the following services:
- Development and validation of analytical methods
- Process optimisation
- Process validation
- Documentation of common technical documents (CTD)
- Production of hospital batches
- Production in laboratory scale as far as 500l-bulks
- Development and optimization of freeze-drying programs
- Stability-tests according to ICH
- Analyses of stressed samples with increased level of contamination
- Development of a suitable packaging design