Clionix provides comprehensive technology transfer services to support the development and implementation of new radiopharmaceutical products in both existing and newly established production facilities.
By applying a Technology Transfer Project Management System compliant with ICH guidelines, we ensure that each transfer is planned, executed, and validated in a systematic, documented, and regulatory-compliant manner.
Our multidisciplinary team offers technical and procedural expertise to help clients establish the necessary infrastructure, optimize facility design, and achieve seamless scale-up from concept to validated production.
| Service Area | Details |
|---|---|
| Technical Infrastructure Assessment | Determination of facility and equipment requirements for the new product or technology |
| Facility Design Revision | Redesign and adaptation of production areas to accommodate new processes |
| Equipment Planning & Procurement | Planning of production and QC equipment, management of procurement processes, and/or direct equipment supply |
| Project Management | Coordinated management of all technology transfer activities, documentation, and schedules |
| Installation & Commissioning | On-site installation, integration, and testing of new devices and systems |
| Documentation & Protocols | Preparation of production protocols, SOPs, and GMP documentation for the transferred process |
| Pilot Productions | Execution of pilot batches to confirm process reproducibility and performance |
| Validation Studies | IQ/OQ/PQ studies to ensure compliance and system readiness |
| Supply of Production Consumables | Provision of necessary consumables to support validation and start-up phases |