Development & Transfer
- The development of formulations and processes, the professional transfer of products and the optimisation of products are key strengths of Rottendorf Pharma.
- We offer you both complete solutions as well as individual services. You will be informed on each stage and each development step – and stay flexible in choosing a place of production. We constantly accompany your product up to the successful completion of the transfer.
- The industrial scaling-up of the galenical results plays a leading role in this context. Individual solutions are elaborated in close collaboration with our customers. Our competent Development & Transfer Team with its long-time experience and its comprehensive know-how as well as state-of-the-art production facilities are at your disposal.
- Our Development & Transfer Center which was constructed in 2009 does not only offer established solid dosage form technologies but also special techniques such as hot melt extrusion and hot melt granulation as well as development and production of pellets. Special emphasis lies on an improved availability of poorly soluble APIs.
Our range of services at a glance
- Development of formulations and processes as well as validation
- Production of stability batches, registration batches and clinical batches
- Process optimisation and update of existing dossiers
- Product transfer
- Optimisation of analytical methods
- Batch release
- ICH stability studies
- Generation of submission files for marketing authorisations and expertises
