Custom Solutions
Contract development & manufacturing
of molecular diagnostic tests
BIOTYPE’s contract development & manufacturing service covers all challenges from the idea up to the realization of a marketable product. As a European Molecular Diagnostic company and a proven OEM supplier, we are committed to high-quality standards and can accommodate individualized product specifications for our international customers.
BIOTYPE Custom Solutions
YOUR One Stop Shop for CDMO Services
Contract Development
- Expertise in molecular and in vitro diagnostics
- Modular development following Design Control Guidelines from idea to CE-IVD market
- Advanced bioinformatic analyses with machine learning and AI for diverse biomarkers
- Adaptable biomarkers and platform technologies
Multiplex Assay Development
- Multiplex primer and assay design
- Assay condition testing and enhancement
- Analytical performance testing
- Clinical performance testing
- Assay manufacturing and ready-to-use delivery
Contract Manufacturing
- Customizable and cost-effective manufacturing, manual or automated
- Adaptable batch sizes under clean room conditions following GLP guidelines
- Efficient supply chain management
- Robust quality control oversight
Custom Packaging
- Tailored packaging design and production
- Customized scale, format, and labeling options
- Alignment with your corporate identity
- High-quality materials from certified suppliers
Regulatory Consultancy
- Regulatory support from idea to marketable product
- Establishment and recording of all required documentation
- Application and CE registration
Quality Management
Our quality management system that fulfills the requirements and the recommendations of the international norms DIN EN ISO 9001:2015 and 13485:2021 or the sales, development, manufacturing, and services of molecular tests for research and in-vitro diagnostic applications.
Our Partners
Contact
Reach out to the BIOTYPE Custom Solutions team for your new project