OEM Contract Manufacturing Services
Our Manufacturing Site is there to give you Convenience and Peace of Mind.
Because we know how important it is for you to reach your return on investment (ROI), we do not limit our services to assay development. We use our professional knowledge and capabilities to support you in the next step...manufacturing.
Even without the development phase there are numerous benefits if you outsource IVD manufacturing to us:
- We make your production(s) conform high quality standard.
- We make the technical transfer from development to production and tackle possible problems in upscaling
- We make all the manufacturing documentation according your request and regulations, to save you time.
We keep an eye on quality by working according to Quality Control and Quality Assurance Procedures that are based on ISO 13485 and cGMP requirements for 21 CFR part 820.
Manufacturing services we offer:
- Full immunoassays (e.g. ELISA, EIA, CLIA)
- Solutions (e.g. buffers)
- Small scale bead coating
- Microtiter plate coating
- Lyophilization of kit components, also accuspheres
- Product filling, capping and labeling
- Final kit box-packaging