Rottendorf Pharma and Corealis Pharma Offer Seamless OSD Development and Manufacturing
Signing the contract at the headquarters of Corealis Pharma in Laval, Canada.
Faster time to market: Integrated early-development offering and accelerated commercial pathway for biotech companies.
Rottendorf Pharma, a globallyleading CDMO with broad oral solid dosage (OSD) development, scale-up andmanufacturing capabilities across the product lifecycle, and Corealis Pharma, aNorth American specialist in early-stage oral solid dosage (OSD) developmentand Phase I and II clinical supply, have expanded their service offering through astrategic partnership. The collaboration offers pharmaceutical and biotechcompanies a strategic transatlantic alliance designed to simplify and de-risk theend-to-end OSD journey by extending and integrating complementarydevelopment capabilities from pre-formulation to global market supply.
This new partnership now formalizesand extends an existing collaborationtowards the development-tocommercializationmodel built onearly technical integration ofmaterial, equipment and processconsistency, and structuredknowledge transfer. This enablesbiotech and pharmaceuticalcompanies to move confidently frompre-clinical and early clinical phasesthrough all subsequent developmentstages and into Phase III scale-up andmarket registration in the US, Europe,and beyond.
Corealis and Rottendorf operate under a joint execution and governanceframework, aligning formulation strategy, analytical methods, manufacturingprocesses, and regulatory expectations from the earliest stages of development.This approach reduces scale-up risk, accelerates timelines, and strengthensreadiness for commercial by progressively integrating development andmanufacturing considerations throughout the program.
“With Corealis, we have gained an ideal partner for early-stage developmentwho complements our own expertise and expands our reach in this area”, saysErich Scheibner, Managing Director at Rottendorf Pharma. “Together, we offerour customers an integrated yet flexible solution that combines scientificexcellence, quality, and reliability across the entire development continuum.”
“Rottendorf brings decades ofexperience in late-stage development,scale-up and commercialmanufacturing of oral solid dosageforms,” adds David Leroux-Petersen,CEO of Corealis Pharma. “Throughthis collaboration, we provide ourbiotech clients a continuoustransition from early-stage developmentto commercial supply –with seamless knowledge transfer."
Built for speed, simplicity, and technical confidence, the alliance operatesthrough a structured framework for data exchange, tech-transfer dossiers, andjoint project teams that integrates commercial manufacturing and late-stagedevelopment requirements early into formulation and process development,aligns materials, equipment and methodologies to reduce scale-up andvalidation risk, and enables a seamless transition from North American clinicaldevelopment to Phase III and commercial manufacturing in Europe.
