Singota is FDA registered and fully cGMP compliant.
Our in-house 21 CFR compliant, validated label creation software allows for the customization of labels including size, content, color, storage conditions, languages, and other necessities. Labeling can be performed for a variety of drug product configurations such as vials, syringes, foil packs, tablets, blister packs, and secondary packaging. Our experience includes labeling of temperature sensitive materials that require strict controls around time out of refrigeration (TOR). We also perform expiry re-labeling, de-labeling/re-labeling, and blind labeling & kitting.
Singota can customize packaging solutions with the options of single, double, or multi cell cartons or cases. Packaging can also be performed for temperature sensitive materials with TOR tracking.
We offer customized kitting for preclinical and clinical trials. We can design kitting for single and double blind studies. Once completed, we can ship directly to the clinical trial site or other requested destinations.
Process & Controls:
Singota has a variety of Standard Operating Procedures (SOPs) in place in order to perform and control processes. Standardized Master Batch Records (MBRs) and complete documentation are provided with material traceability and reconciliation.
Before or after production operations, we can store material in our GMP-compliant warehouse, which includes 25,000 square feet of controlled room temperature storage and 19,000 square feet of 2-8°C.
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