Contract development & manufacturing or IVD regulatory support
We can help in you many ways. Leverage our expertise!
Our research team has a combined experience of more than 25 years in molecular biology and diagnostics. We are knowledgable and passionate in the field of rapid nucleic acid extraction. If you have your main competence in assay development then contracting us for a smart and high-performing nucleic acid extraction protocol is the best way to move forward. If you are looking for a competent and trustworthy partner for contract development of nucleic acid extraction solutions, you may consider to contact us to learn more. We can support your team with our in-house expertise and development capacities.
Beyond development, we offer several opportunities to leverage our extraction products to your advantage. We are open for licensing of our SwiftX technology to you or for OEM manufacturing of our kits under your brand.
Our founder, Dr. Andy Wende, has been working as Auditor and Product Assessor for several years at TÜV SÜD, one of the largest Notified Bodies for Medical Devices. His deep knowledge in Regulatory Affairs and Quality Management is leveraged to guarantee that our own products are in full compliance with regulatory requirements and to minimize the time-to-market for our IVD medical devices.
Whether you are an IVD manufacturer or a diagnostic laboratory: you can benefit from our comprehensive regulatory expertise!