Faster time to market: Rottendorf Pharma and Corealis Pharma Offer Seamless OSD Development and Manufacturing
Integrated early-development offering and accelerated commercial pathway for biotech companies
- Strategic transatlantic alliance: Integrated early- to late-stage OSD development from pre-formulation through commercial supply.
- Clear role allocation: Corealis leads R&D and Phase I–II clinical supply; Rottendorf manages Phase III, validation, and commercial manufacturing.
- Faster, lower-risk development: Early technical integration and structured knowledge transfer accelerate timelines and reduce scale-up risk.
11.02.2026, Laval, Québec (Canada) / Ennigerloh. Rottendorf Pharma, a globally leading CDMO with broad oral solid dosage (OSD) development, scale-up and manufacturing capabilities across the product lifecycle, and Corealis Pharma, a North American specialist in early-stage oral solid dosage (OSD) development and Phase I and II clinical supply, have expanded their service offering through a strategic partnership. The collaboration offers pharmaceutical and biotech companies a strategic transatlantic alliance designed to simplify and de-risk the end-to-end OSD journey by extending and integrating complementary development capabilities from pre-formulation to global market supply.
This new partnership now formalizes and extends an existing collaboration towards the development-to-commercialization model built on early technical integration of material, equipment and process consistency, and structured knowledge transfer. This enables biotech and pharmaceutical companies to move confidently from pre-clinical and early clinical phases through all subsequent development stages and into Phase III scale-up and market registration in the US, Europe, and beyond. Corealis and Rottendorf operate under a joint execution and governance framework, aligning formulation strategy, analytical methods, manufacturing processes, and regulatory expectations from the earliest stages of development. This approach reduces scale-up risk, accelerates timelines, and strengthens readiness for commercial by progressively integrating development and manufacturing considerations throughout the program.
“With Corealis, we have gained an ideal partner for early-stage development who complements our own expertise and expands our reach in this area”, says Erich Scheibner, Managing Director at Rottendorf Pharma. “Together, we offer our customers an integrated yet flexible solution that combines scientific excellence, quality, and reliability across the entire development continuum.”
“Rottendorf brings decades of experience in late-stage development, scale-up and commercial manufacturing of oral solid dosage forms,” adds David Leroux-Petersen, CEO of Corealis Pharma. “Through this collaboration, we provide our biotech clients a continuous transition from early-stage development to commercial supply – with seamless knowledge transfer."
Built for speed, simplicity, and technical confidence, the alliance operates through a structured framework for data exchange, tech-transfer dossiers, and joint project teams that integrates commercial manufacturing and late-stage development requirements early into formulation and process development, aligns materials, equipment and methodologies to reduce scale-up and validation risk, and enables a seamless transition from North American clinical development to Phase III and commercial manufacturing in Europe.