Workflow stages
Uniogen can support individual phases or provide end-to-end development services, from early-stage design to compliant lifecycle management.
Contact us and let’s find a solution that best suits your needs.
1. Product assessment
- Product status: early-stage to manufacturing
- Availability of protocols, reagents, and materials
2. Development and feasibility
- Technology options: immunochemistry, PCR
- Solid phases: microplates, LF strips
- Detection methods: ELISA, TRF, Upcon, etc.
- Support: conjugation services and instrumentation
- Assay development and consultation services
- Assessment of manufacturing feasibility
3. Production transfer
- Scale-up
- Verification as required
- Validation as required
4. Routine production
- Bulk production
- Filling, capping, sealing
- Quality control testing as required
5. Life-cycle management
- After-sales support
- Stability studies as required
Individual phases or end-to-end development services can be provided in accordance with ISO 13485, as required.