Answers to the most common operational, logistical, and regulatory questions from our distribution partners and prospective partners.
MOQ varies by partnership tier and territory. Specific volumes are detailed in the distributor pack. Contact our partnership team for your market's MOQ.
CCI Reagent is stored at room temperature (15–30 °C). No cold chain required. Keep in original sealed packaging until use. Avoid direct sunlight and moisture.
Standard lead time is communicated per territory in the distributor pack. Expedited shipping is available upon request at additional cost.
Yes. Evaluation samples are included in the distributor pack provided after NDA signing. Additional samples can be arranged for internal testing and sales team training.
After signing the distribution agreement, we work with your team to define packaging design, labeling, and IFU localization. Regulatory review is conducted jointly to ensure CE-IVD compliance is maintained. Minimum production runs apply for OEM configurations.
We provide: product brochures (multilingual), sales training presentations, clinical summary documents, graphic assets for packaging and promotional use, and localized copy kits. A dedicated partner manager supports you through the onboarding period.
Our complaint handling process is defined in the distributor agreement. Report quality concerns through the distributor portal or directly to our QA team. We maintain a defined response SLA and manage all post-market surveillance obligations.
We monitor regulatory developments and proactively communicate changes that affect distributed products. IVDR transition planning is included in our regulatory roadmap, and we support distributors through required documentation updates.
Request the distributor pack — including regulatory documentation, pricing tiers, and logistics specifications. No commitment. Full transparency.
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