ISO 13485-certified manufacturing with integrated CMO/CDMO development capabilities and scalable technology transfer services. Reliable execution from development to large-scale production.
01
CMO/CDMO Development
We offer both CMO and CDMO services. As a CMO, we provide contract manufacturing under defined specifications. As a CDMO, we additionally support development activities, including new product development, assay adaptation, optimization, and format adjustments. This may include refining existing lateral flow immunoassays or developing new solutions to meet specific technical, regulatory, or market requirements.
02
ISO 13485 manufacturing
Manufacturing is performed under an ISO 13485-certified quality management system, ensuring compliance with international medical device standards. All processes are controlled through defined procedures, documentation, and quality checks, supporting consistent production and traceability across all stages of manufacturing.
03
Scalable tech transfer
We support the transition from technical concept or transferred process into stable, scalable manufacturing. This includes aligning materials, process parameters, and quality controls to ensure reproducibility and efficiency as production volumes increase.