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