Corealis Pharma provides formulation and process development services as well as phase I and II Clinical Trial Material manufacturing of oral dosage forms (tablet, capsule or granule) to the pharmaceutical and biotech companies.
Corealis can take the complete development or provide you with very specific development steps such as:
•API characterization and salt selection
(e.g., crystal state, particle size, solvates, hygroscopicity, stability, solubility);
(e.g., Drug-drug compatibility, drug-excipients compatibility, compressibility, flow);
•Formulation and product development
(i.e., direct compression, wet granulation ( high shear and FBG), dry granulation (roller compaction), spray dry (aqueous/ solvents), extrusion/spheronization, hot melt extrusion, tableting and encapsulation (dry powder, granules, hot melt, suspension and solution);
•Analytical method development and GMP testing
(e.g., Assay & related substances, dissolution);
•Phase I and II cGMP Clinical Trial Material (CTM) manufacturing and packaging;
•GMP stability storage and testing;
•Analytical method transfer;
•Formulation and process transfer and scale-up.
Corealis experts have at their disposal R&D and GMP labs and manufacturing suites that are fully equipped to tackle the most challenging mandates.
Corealis is responsive, flexible and provides high quality services to move compounds quickly through the different development steps to regulatory approval.
For more information about Corealis Pharma please visit our website at www.corealispharma.com.