Expertise that moves you from idea to compliant product.
Bioparticle has partnered with Unplex® to bring a powerful trio of services to medtech and biotech innovators — combining scientific depth in nanoparticles, regulatory rigor, digital systems, and engineering under one roof. Faster, and smarter.
Expertise in EVs, nanoparticles, nanobubbles & VLPs
Accelerate discovery, streamline analytics, and scale production for biological and synthetic nanoparticles — with consultants who work in this space every day.
- Workflow design & feasibility — isolation, purification, characterization
- Process development & scale-up from bench to pilot and GMP
- Characterization & analytical strategy across NTA, flow, and microscopy
- Regulatory & quality readiness aligned to cGMP expectations
- Commercialization & partnership strategy
Navigate compliance with confidence
Leverage deep regulatory expertise so your innovations meet global standards — from ISO 13485 to FDA 21 CFR Part 820 and MDR — while you stay focused on the science.
- QMS implementation & auditing (ISO 13485, FDA, MDR)
- IEC 62304 software lifecycle & technical documentation
- Technical file creation & regulatory submissions
- Risk management and usability engineering
- Regulatory strategy for international markets (FDA, CE)
Unify operations with Odoo ERP
Get more from your business processes with customized Odoo ERP implementations built for growing medtech and biotech companies — from inventory to CRM to regulatory document control.
- Custom Odoo ERP setup & module development
- Integration with R&D, QA/RA, and supply-chain workflows
- Secure data management and document traceability
- Ongoing support and training
Concept to pilot production — one stage at a time
Unplex® brings deep-tech product development across the full lifecycle, honed on medical devices, defense, and industrial automation and applied here to life-science instrumentation and diagnostics. Step through the nine stages to see what each delivers.
Industrial Design
We translate the concept into an industrial-design language — ergonomics, enclosure, and interaction — so an instrument feels considered the moment it lands in the lab. Every later engineering decision is grounded in how researchers will actually reach for it.
- Concept sketches and form studies
- Ergonomics and bench footprint
- Brand-aligned enclosure and finish
Across the research-to-commercial path.
Academic and translational research labs
Biotech and biopharma companies
CROs and CDMOs working with EVs, LNPs, viruses, or VLPs
A Bioparticle × Unplex® partnership.
Unplex® is a deep-tech product development and manufacturing partner spanning medical devices, defense, and industrial automation — with teams in Tucson, Bengaluru, and Ontario.