OEM and custom PCR kit development
Custom PCR kit development
We can manufacture molecular diagnostic assays lyophilised and in liquid formats with master mix containing all the components needed for amplification. Hola Biolabs has ISO13485 certification for design, development and production of medical devices for "in-vitro" diagnostics and has significant experience in manufacturing products.
We can provide the following services:
- Assay design
- Prototype testing
- Assay pre-feasibility and optimisation
- Assay validation
- Stability studies
- Technical file creation
- Validation on selected MDx platforms
OEM cooperation module
Our products are available on an OEM basis. We are open to managing the entire OEM process for your organization. This collaboration brings complete integration of your brand into our workflow to ensure your products are packaged and specified in your preferred format.
One of the options is to supply our products under the white label for your own packaging systems. Another option is to create new packaging solutions based on your specifications with your own branding. Or we can pack the products directly in to your own packaging solution. Product handbooks and protocols can be rebranded too.
We can become your remote operations department to can take orders, package kits, ship to and invoice your customers directly under your own brand.
Hola Biolabs real-time PCR reagents are manufactured to the highest standards within our ISO 9001:2016 and ISO13485:2016 quality management laboratory facility.
Reasons to work with us
We are team with a high level of expertise: We are a team with many years of experience with PCR, from the design and development of kits through production and standardization to our own practical application in the diagnostic laboratory.
We have tested more than 200,000 patients in our own laboratory. We implement our own experience during development and production with the aim of user comfort of our products.
We focus on the needs of our customers and are open to discussion. We believe that together we are better.
We are a certified laboratory and we develop our product in accordance with CE IVD.