Manufacturing
Our FDA registered and ISO 13485 certified manufacturing facilities allow us to provide everything from small-scale pilot batch manufacture to full commercial production, with a range of automated liquid dispensers, semi-automated plate sealers and bag sealers.
We will carry out a full transfer to production process, with triple batch validation, to ensure your products are made to the highest of standards.
We can provide a full range of manufacturing services, including:
Manufacture of both molecular diagnostic and immunoassay kits
Technology transfer from development to production
Coating, blocking and drying of microtiter plates
Freeze dry and stabilisation of molecular diagnostics reagents using our state of the art temperature and humidity controlled (down to 5%) clean room facilities
Triple batch manufacture and creation of manufacturing records to ISO 13485 compliance
Development of detailed QC procedures
Full validation of final IVD kits
Regulatory assistance for CE and FDA submissions
Contact Biofortuna for a discussion on our capabilities.
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