- Rottendorf Pharma and Corealis Pharma have formalized and expanded a strategic transatlantic partnership focused on oral solid dosage (OSD) development and commercial manufacturing.
- The alliance integrates early-stage development with Phase III scale-up and global market supply through a joint governance and execution framework.
Rottendorf Pharma and Corealis Pharma have expanded their collaboration through a strategic partnership designed to streamline the end-to-end oral solid dosage (OSD) development journey. The transatlantic alliance combines Corealis’ early-stage OSD development and Phase I and II clinical supply expertise with Rottendorf’s capabilities in late-stage development, scale-up, and commercial manufacturing.
The partnership formalizes an existing collaboration and extends it into a structured development-to-commercialization model. Under a joint execution and governance framework, the companies align formulation strategy, analytical methods, manufacturing processes, and regulatory expectations from pre-formulation through market supply. The approach is designed to reduce scale-up risk, accelerate timelines, and strengthen commercial readiness.
Through this integrated pathway, biotech and pharmaceutical companies can transition from pre-clinical and early clinical phases at Corealis in North America to Phase III scale-up and market registration in the United States, Europe, and other regions through Rottendorf. The alliance emphasizes early technical integration of materials, equipment, and process consistency, supported by structured knowledge transfer.
“With Corealis, we have gained an ideal partner for early-stage development who complements our own expertise and expands our reach in this area.”
Erich Scheibner, Managing Director at Rottendorf Pharma
The collaboration operates through a structured framework for data exchange, tech-transfer dossiers, and joint project teams. The companies stated that integrating commercial manufacturing considerations early into formulation and process development is intended to reduce validation risk and enable a seamless transition from North American clinical development to Phase III and commercial manufacturing in Europe.
