Together, We Will Catalyze Change
Leverage our end-to-end expertise in assay development and regulated manufacturing to accelerate your diagnostic pipeline, from initial concept to global market launch.
Our Collaborative Process
1- Consultation & Feasibility
We begin with a deep dive into your project goals, technical requirements, and regulatory strategy to define a clear and achievable path forward.
2- Development & Optimization
Our dedicated scientists develop and rigorously optimize the assay, focusing on key performance characteristics like sensitivity, specificity, and stability.
3- Validation & Manufacturing
We perform comprehensive analytical and clinical validation, followed by a seamless technology transfer for scaled-up manufacturing under strict quality control.
4- Delivery & Post-Market Support
We deliver a complete, market-ready solution with ongoing technical, manufacturing, and regulatory support to ensure your long-term success.
Our Core Competencies
We provide a comprehensive range of services built on a foundation of cutting-edge technology and deep scientific expertise to function as a seamless extension of your team.
Immunoassay Development
End-to-end development and validation of robust immunoassays (TRFIA, LFA, ELISA) for your specific biomarker and platform requirements.
Reagent & Antibody Services
Production of high-quality monoclonal/polyclonal antibodies and recombinant antigens with guaranteed performance characteristics.
Bioconjugation Expertise
Leverage our deep expertise in conjugating antibodies and antigens to various labels, including our proprietary Europium nanoparticles for TRFIA.
ISO 13485 Scale-Up Manufacturing
Transition seamlessly from pilot-scale to large-scale, automated production in our certified facilities under strict quality control.
Regulatory Strategy & Support
Receive expert guidance and technical file support for navigating complex regulatory pathways including CE-IVDR and FDA 510(k) submissions.
Digital Platform Integration
Develop custom software solutions to integrate your new diagnostic with our connected health ecosystem for enhanced data management.
Partner Success Stories
We pride ourselves on building strong, collaborative partnerships that lead to tangible, market-moving results.
Ready to accelerate your R&D pipeline?
Let’s discuss how our expertise and infrastructure can help you achieve your diagnostic development goals.