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Clinical Trial Supplies

Mikart offers a comprehensive range of clinical supply services for solid oral dose and non-sterile liquid products. We can manufacture, package, label and distribute your clinical trial materials for later phase (III & IV), multi center, open-label and double-blind randomized studies. Our services are cGMP, GCP and GLP compliant and include established procedures in accordance with the CFRs and ICH Guidelines.

Services:

  • Phase III & IV Manufacturing and Packaging (cGMP Compliant Facilities)
  • Randomized, Double Blind, Two/Three Panel Label Capabilities
  • Customized Packaging Design
  • Custom Secondary Packaging & Patient Supply Kits
  • Child-Resistant Packaging
  • Analytical Testing Services
  • Over-Encapsulation
  • CII – CV Controlled Drug Manufacturing & Packaging
  • Placebo Manufacturing

We can package the following dosage forms:

  • Tablets
  • Capsules
  • Soft-gels
  • Non-sterile Liquids
  • Powders/Granules (bottle only)

Our clinical packaging options include:

  • HDPE, PET & Glass Bottles
  • Laminated Foil Pouches/Strip Packs
  • Thermoformed & Cold-Formed Blisters
  • Carded Blisters