IVD Quality & Regulatory Services
There are an ever-increasing number of regulations, rules, and guidelines that govern the world healthcare industry. Navigating through the regulatory hurdles associated with in vitro diagnostics can be a challenging endeavor. With the help of the quality engineers and experienced scientist at nanoComposix, it doesn’t have to be. Our team will guide you step-by-step through the process in order to mitigate risk and expedite the process. Whether you are just transitioning your product out of R&D or assembling a pre-submission packet, nanoComposix can help your test become an indispensable part of the world healthcare system.
- Transition Assistance: Transferring from R&D to Design Control to Manufacture
- Creation of deliverables: Risk Management Plan, Manufacturing Strategy Plan, Design Input Requirements, Customer Needs Summary, etc.
- Drafting and/or Execution of Verification Protocols
- Manufacturing Transfer
- Assembly of submission packets and guidance through responses
NanoComposix provides full-service lateral flow assay development services using novel ultra-sensitive nanoparticle reporters, covalent binding chemistry, and quantitative smartphone-based reader technologies.
We Can Help at Any & Every Step
- Technical support for selection of BioReady nanoparticles and successful integration into your system
- Full contract lateral flow assay development or flexibility to assist with any Phase in your development cycle
Why Choose nanoComposix?
- ISO13485 compliant in-house manufacturing of prototype lots with up to 50,000 test strips and scaled manufacturing partners worldwide for larger quantities
- Development of competitive and sandwich assay formats for the detection of wide variety of analytes including protein hormone, steroid hormone, protein/protein complex, peptide, serological response (IgM & IgG antibodies), drugs of abuse, fungal infection, bacteria, and virus
- Integration with multiple reader technologies for rapid, mobile, and quantitative point of care applications
- Over $5 million awarded for government contracts to develop next generation lateral flow devices