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