BioConvergence provides labeling, kitting, and packaging services for the pharmaceutical and animal health industries. We specialize in small volume jobs needing quick turnaround with demanding specifications and customized requirements, or require manually intensive procedures to avoid tooling and expensive set-up costs.
- Pre-Clinical Studies
- Clinical Trials
- Blinded Studies
- Commercial Products
- Mergers & Acquisitions with Re-packing Requirements
BioConvergence 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.
- BioConvergence 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 and Controls:
- BioConvergence 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.
To learn more about our production capabilities, contact us.