From lab bench
to certified
product.

We help diagnostics companies and researchers turn lateral flow assays into commercially ready products — from nanoparticle conjugation and strip design through to clinical validation and regulatory compliance.

01
NP Synthesis
02
Bioconjugation
03
Strip Architecture
04
Optimisation
05
Clinical Validation
06
Certification
10+
Years end-to-end
LFA experience
10+
Products taken from
research to market
2
ISO quality frameworks:
9001 · 13485
LabMarket
Full product lifecycle,
no handover gaps
About LateralSys

We fill the gap between a working prototype and a marketable product.

Wet lab chemistries often show promising results early on. The real challenge shows up during translation onto lateral flow strips tested in the real world — as inconsistent performance, stability issues, failed validation, or missing standards compliance. We provide support at any stage of this process.

Within our team, we have direct experience developing lateral flow assays for different biological fluids designed to meet IVD regulatory compliance, and preparing for independent evaluation. We have also developed point-of-care lateral flow assays for infectious diseases, taking them from early-stage research in academic labs through to commercially viable products in clinical trials.

Whether you're in academia or industry, our end goal is the same — to make a lateral flow strip that works.

Our work covers the full development cycle — from nanoparticle conjugation and strip design through to optimisation, clinical validation, and preparation for standards-based testing. We are not a referral service; when we take on a project, we do the work.

Who we work with

Academics
You have the science right, but translating it into a robust, reproducible product ready for real-world use requires an industry perspective that is rarely developed at the lab bench.
Entrepreneurs & Diagnostics SMEs
You understand the market opportunity but need the technical depth to build a development program that delivers. We bring hands-on experience across the full cycle — assay design, optimisation, clinical validation, and regulatory preparation.
Product Teams Hitting a Wall
Your assay looks promising in the lab but is underperforming in the real world — low sensitivity, high background, or instability under manufacturing conditions. We step in at any stage to diagnose, fix, and move forward.
What We Do

End-to-end capability across the full LFA lifecycle.

Every service is delivered from a single point of accountability — the same expertise that designs your conjugation system also supports your clinical trial and prepares your regulatory documentation.

Development
LFA Product Development
  • Nanoparticle synthesis and bioconjugation
  • Strip architecture and component optimisation
  • Sensitivity, specificity, and matrix effect work
  • Reader integration and cut-off algorithm development
  • Scale-up and transfer to commercial manufacture
Regulatory
Validation & Regulatory Preparation
  • IVD regulatory compliance (IVDR) preparation
  • Performance benchmarking against applicable standards
  • Independent laboratory QC method development
  • Clinical trial design, execution, and reporting
  • Technical documentation for regulatory submissions
Quality
Quality Systems
  • ISO 13485 quality management for IVD medical devices
  • ISO 9001 quality frameworks for diagnostics products
  • Document control, CAPA, deviation management
  • SOP writing and process design
  • GMP audit readiness, including first-time applicants
Facility
Facility Design & GMP Setup
  • LFA facility layout, zone design and material flow
  • Dry room specification and environmental monitoring
  • Cleanroom classification and HVAC brief
  • Equipment IQ/OQ/PQ and calibration systems
  • Full SOP library written from first principles
Research
Bridging Research & Industry
  • Translating academic prototypes into manufacturable products
  • Fixing low sensitivity, high background, or unstable assays
  • R&D programs structured to produce regulatory-ready evidence
  • Understanding GMP constraints before they become costly
  • Supporting the pivot from publication to product mindset
Training
Staff Training & Capability
  • GMP fundamentals for teams new to regulated environments
  • Hands-on LFA manufacturing technical training
  • Competency frameworks and training documentation
  • Ongoing support as your team grows
Quality Frameworks

Knowing which framework your product actually needs.

One of the most costly mistakes in LFA development is applying the wrong quality framework from the start. Getting this right shapes everything — your facility, your documentation, your clinical program, and your timeline.

IVD Medical Devices
ISO 13485
A comprehensive medical device quality management system — covering design history files, risk management, and clinical evidence requirements. We have led ISO 13485-aligned programs from early research through to clinical trials across multiple biological matrices.
General Diagnostics Products
ISO 9001
A structured quality management framework applicable to a broader range of diagnostics products. For many first-facility builds, ISO 9001 is the right starting point — achievable without the full overhead of a medical device QMS, yet rigorous enough for real-world manufacturing.
Regulatory Compliance
IVDR & Standards-Based Testing
IVD regulatory requirements vary by market and application. We have direct experience designing assays to meet performance standards from the start and preparing products for independent evaluation — so that regulatory submissions are grounded in solid, reproducible evidence.
Working with Us

Structured to suit your project.

Engagements are scoped to the problem — from focused technical sprints to longer advisory retainers. Remote and on-site arrangements are both available; location is not a constraint.

01
Project-Based
Defined scope, milestones, and deliverables. Suited to formulation optimisation, clinical trial design, standards compliance preparation, or any well-bounded technical problem. You know what needs to happen and when.
02
Technical Advisory Retainer
Ongoing access for troubleshooting, strategy, and regulatory guidance. Best for teams actively building — where questions come up continuously and having experienced technical support on call compresses decision time significantly.
03
Documentation Packages
ISO 13485-aligned technical documentation — SOP development, equipment calibration systems, supplier qualification frameworks, and audit readiness preparation written from first principles, not adapted templates.

Five reasons lateral flow assays fail — and what to do about them.

Most development failures aren't random. They follow predictable patterns. Here's what we see most often, and how to get unstuck.

01
Antibody selection isn't validated for the matrix
Antibodies that perform well in buffer often behave very differently in oral fluid or urine. Matrix components — proteins, pH, ionic strength — can interfere with binding, drive non-specific signal, or dramatically shift your cut-off. If your assay works in buffer but fails in the intended sample type, this is almost always the first place to look.
02
The conjugate is optimised in isolation
Conjugate optimisation is usually done in solution — then the conjugate hits the membrane and behaves completely differently. Flow dynamics, membrane chemistry, and pad interactions all affect performance in ways that solution-phase testing won't predict.
03
Variability is treated as noise rather than signal
When results are inconsistent between runs or operators, the instinct is often to tighten the cut-off or average it away. But variability is usually pointing to something specific — humidity sensitivity, conjugate pad loading, or a membrane lot-to-lot issue. A structured DOE approach almost always finds the root cause faster than ad hoc troubleshooting.
04
Scale-up is treated as a hand-off, not a translation
The step from R&D prototype to manufactured product is where many assays quietly fall apart. Dispensing equipment, drying conditions, assembly tolerances — each introduces variability that a lab-bench process silently absorbed. A process capability study before scale-up protects your development investment.
05
QC is an afterthought. It should be a foundation.
Most teams treat QC testing as the final step before submission. It shouldn't be. A QC protocol designed after the assay is locked will generate evidence that is hard to reproduce, doesn't hold up at independent laboratory testing, and fails at validation. QC design needs to run alongside product optimisation — same timeline, not after it. The matrix you choose determines whether real failure modes surface during development or during certification. Get it wrong and you repeat significant parts of development.

Most assay problems are diagnosable.

The key is systematic elimination — starting with the most likely root cause and working outward. If your strip isn't performing and you're not sure why, a one-hour diagnostic conversation usually identifies the problem.

FAQ Get in touch

Let's talk about your project.

Whether you're an academic with a promising LFA technology wondering what it takes to get to market, or a diagnostics company finding that real-world performance isn't matching lab results — we'd like to hear from you.

Location Remote & On-site
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