Contract Formulation Development and Clinical Trial Manufacturing Services for Oral Solid Dosage Forms
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As a privately owned company located in Montreal, Canada, Corealis Pharma assists small and medium pharmaceutical companies in their pharmaceutical development needs by offering a complete line of services for formulation development and phase I and II clinical trial manufacturing of oral solid dosage forms.
Increase the market value of your company and its attractiveness to investors by involving Corealis formulators early in your drug development process.
Phase I and phase II CTM manufacturing
The company prides itself on providing personalized services with fast project start-up and 100% on-time delivery. The entire team has relevant background, expertise and experience, and can rely on modern and well-equipped laboratories. Since the inception of the company in 2005, over 200 drug products have been successfully developed and more than 65 phase I and phase II CTM manufactured.
Integrated pharmaceutical development and manufacturing
Corealis has all of its activities and operations in one location, a new 35,000ft² state-of-the-art R&D formulation development, analytical laboratory, and manufacturing facility fully compliant to EMEA, USFDA and Health Canada GMP requirements.
Formulation development of new chemical entities
Corealis develops formulations of new chemical entities for the manufacturing of phase I and II clinical supplies for Canadian, US and European submissions. This service is specifically designed for biotech companies.
Using final or close to final dosage forms in pre-clinical and clinical trials greatly reduces the chance of failure and costly justification in submissions.
Pharmaceutical product development and manufacturing services
Corealis can undertake complete pharmaceutical product development or provide companies with very specific development steps such as:
- API characterization and salt selection (crystal state, particle size, solvates, hygroscopicity, stability, etc.)
- Pre-formulation (drug-drug compatibility, drug-excipients compatibility, compressibility, flow, etc.)
- Formulation and product development: direct compression, wet granulation (high shear and FBG), dry granulation (roller compaction), spray dry (aqueous / solvents), extrusion, spheronization, tableting and encapsulation (dry powder, granules, hot melt, suspension and solution)
- Analytical method development and GMP testing (assay and related substances, dissolution, etc.)
- Analytical method transfer
- GMP stability storage and testing
- Formulation and process transfer and scale-up
- Phase I and II cGMP clinical trial material (CTM) manufacturing
Corealis is responsive and flexible, and provides high-quality services to move your compound quickly through the different development steps to regulatory approval.