COREALIS PHARMA

MANUFACTURING AND PACKAGING

COREALIS Pharma offers clinical supply manufacturing and packaging services for oral solid dosage forms (tablets, capsules, and granules) for clinical studies to be held in the US, Europe, and Canada. This process may begin with the manufacturing of R&D/scale-up batches followed by GMP clinical supplies manufacturing. The dose strength drug products and their matching placebos can be manufactured using the following processes:

• Direct compression,
• Dry granulation,
• Wet granulation,
• Melt granulation
• Extrusion/ spheronization,
• Blending,
• Drying,
• Encapsulation (API-in-a-capsule by weight filling and by volume filling),
• Coating.

The manufacturing of clinical batches can be tailored for:

• Clinical batches for exploratory studies (IND),
• Clinical cGMP batches for Phase I, II, III, and bioequivalence studies,
• cGMP batches for submission to regulatory agencies, and
• cGMP placebos identical to the dose strength drug products.

COREALIS Pharma also offers small scale GMP clinical trial material packaging and clinical supplies material management and warehousing.

The clinical trial material packaging services includes:

• Blisters,
• Bottling,
• Pouching,
• Blind or double blind packaging,
• Patient kit preparation,
• Clinical supplies warehousing and management.