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Manufacturing and packaging

Corealis provides high-quality clinical manufacturing and packaging services for pharmaceutical oral solid dosage forms.

As a specialist in pharmaceutical oral solid dosage (OSD) clinical manufacturing, Corealis is prepared for OSD requests, requirements, and complexities. That includes tablets, capsules, pellets, granules, and powders, with expertise extending to clinical studies conducted worldwide.

The Corealis team creates scale-up batches before producing GMP clinical supplies. The company can generate both dose-strength drug products and their matching placebos.

Corealis has access to an array of packaging configurations for a range of drug products and clinical supply requirements. The packaging solution will always be tailored to meet the client’s specific needs for a clinical study protocol and can be incorporated into the drug product’s formulation development process.

Whatever the project, the team creates high-quality solutions that align with regulatory standards, while ensuring that eventual commercialization.

Manufacturing capabilities

Corealis’ manufacturing capabilities for Immediate Release and diverse Modified Release formulations of one or several API formulations include:

  • Tableting
  • Encapsulation (pure API, powders, tablets, pellets, granules, multi-particulates)
  • Dry granulation (RC)
  • Wet granulation (FBG, high and low shear)
  • Amorphous enabling technologies (spray-drying (aqueous/solvents), coprecipitate dispersion, and melt extrusion)
  • Melt granulation
  • Extrusion and spheronization
  • Coating aesthetic and functional (FB and pan)
  • Packaging (bottle, blister, sachet) and labeling
  • Patient kit preparation (wallet, boxing) for blinded clinical studies
  • Clinical supplies management (warehousing, distribution, reconciliation)

Other capabilities include:

  • Prototype formulation development
  • Manufacturing of prototype formulations for stability (to support IND filling) and animal PK studies
  • Clinical cGMP batches for Phase I, II, and early Phase III studies
  • Matching placebos development and manufacturing

Learn more about manufacturing and packaging

Contact the team today.

Clinical trials packaging

Corealis provides clinical trial packaging services for Phase I, II, and early Phase III studies GMP trials. An essential aspect of clinical operations is managing and storing clinical supplies material, to which Corealis offers clinical material packaging services including:

  • Blisters
  • Bottling
  • Pouching
  • Blind or double-blind packaging
  • Patient kit preparation
  • Clinical supplies management (warehousing, distribution, and reconciliation)

How Corealis can help

Corealis offers comprehensive and experienced support for large-scale manufacturing of clinical supplies, ensuring a smooth transition to Phase III and commercial-scale production. When clients are ready to manufacture submission batches required for NDA or ANDA filings or in any other situations deemed appropriate. Corealis facilitates efficient and streamlined technology transfer, optimizing formulations and manufacturing processes for a seamless scale-up.

Leveraging deep industry expertise, Corealis assists in selecting the right CMO, ensuring manufacturing processes are effectively transferred to the chosen facility with minimal disruption. If challenges arise during manufacturing, the Corealis team is well-equipped to troubleshoot and implement practical solutions, keeping production on track while maintaining high-quality standards.

pharma packaging

Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.