Corealis Pharma
Description
Corealis Pharma is a Canadian contract development and manufacturing organisation (CDMO) specialising in the formulation development and clinical supply manufacturing of solid oral dosage forms, including tablets, capsules, and granules. Established in 2005 by three senior scientists, the company operates from its headquarters in Laval, Quebec.
Since its inception, Corealis Pharma has been committed to partnering with pharmaceutical and biotechnology industries to advance drug development processes. The company's focus lies in delivering high-quality, phase-appropriate drug products that meet stringent client and regulatory standards. By leveraging its specialised expertise in solid dose clinical formulation development and clinical supply manufacturing, Corealis Pharma ensures that drug formulations progress smoothly through all phases of clinical development.
Key Products and Services
Formulation Development Services:
Pre-formulation: Comprehensive analysis of active pharmaceutical ingredients (APIs) to determine optimal formulation strategies.
Formulation: Development of robust and scalable formulations tailored to specific drug properties and therapeutic goals.
Analytical: Development and validation of analytical methods to ensure the quality and stability of drug products.
Clinical Supply Manufacturing:
Manufacturing & Packaging: cGMP-compliant production and packaging of clinical trial materials for Phase I, II, and early Phase III studies.
Release and Stability: Comprehensive testing to ensure product integrity throughout its shelf life.
Technical Transfer and Dossier Reports: Efficient transfer of manufacturing processes and preparation of regulatory submission documents.
Corealis Pharma's dedication to excellence, personalised service, and adherence to regulatory guidelines position it as a reliable partner in the pharmaceutical industry. By offering turn-key solutions and expertise in early-phase drug development, the company continues to support clients in bringing innovative therapies to market efficiently and effectively.