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Manufacturing & 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 ready to meet clients’ OSD needs. 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 is considered throughout.

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. Another important facet of clinical operations is managing and storing clinical supplies material.

The clinical trial material packaging services include:

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

How Corealis can help

Comprehensive support is provided when larger-scale manufacturing batches of clinical supplies are needed, when the client is ready to manufacture submission batches (required to file an NDA or ANDA), or in any situations deemed suitable by the client. Corealis can help find an appropriate CMO and assist in the transfer of formulations and manufacturing processes to a selected manufacturing site.

If any problems arise during manufacturing, the team is well placed to troubleshoot and find practical, implementable solutions.

Contact Corealis

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