From lab bench
to certified
product.

We help diagnostics companies and researchers turn lateral flow assays into commercially ready products — from the chemistry and strip design all the way through to a working device ready for market.

01
NP Synthesis
02
Bioconjugation
03
Strip Architecture
04
Optimisation
05
Clinical Validation
06
Certification
10+
Years end-to-end
LFA experience
10
Products certified to
national standards
3
ISO quality frameworks:
9001 · 27001 · 13485
LabMarket
Full product lifecycle,
no handover gaps
About LateralSys

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

There is no shortage of good ideas in the LFA space. What holds teams back is the transition — from a working prototype to a product that can be manufactured consistently, validated clinically, and certified to the standards a regulator actually requires.

Having worked within small and medium-sized diagnostics businesses, we know what it takes to make R&D work alongside — not against — a Quality department. That interdepartmental reality is something most technical consultants have not lived inside.

We bring industrial insight to science, and scientific rigor to industry. Without both, products fail.

Our work spans the full development arc — from initial feasibility and method development through to performance validation and submission-ready documentation. 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 GMP‑compliant, scalable product 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 will survive regulatory scrutiny. We bring hands-on experience in facility setup, quality systems, and product development — not just advisory.
Product Teams Near Certification
Your assay performs in the lab but breaks under manufacturing or regulatory conditions. We step in at any stage: stabilise performance, close documentation gaps, and get you to certification faster.
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 designed your conjugate also runs your clinical trial and writes your SOPs.

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
Certification & Validation
  • AS/NZS 4760:2019 — oral fluid drug screening
  • AS/NZS 4308:2023 — urine drug screening
  • Independent laboratory QC method development
  • Clinical trial design, execution, and reporting
  • Independent assessment reports for submissions
Quality
Quality Systems
  • ISO 9001 + ISO/IEC 27001 for drugs of abuse IVDs
  • ISO 13485 for infectious disease diagnostic LFAs
  • 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
  • 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.

Drugs of Abuse IVDs
ISO 9001 + ISO/IEC 27001
A significant but manageable framework for a first facility. Covers management systems and information security requirements applicable to workplace drug screening products. This is where most Australian oral fluid and urine drug testing products sit.
Infectious Disease Diagnostics
ISO 13485
A substantially more demanding medical device quality system — including design history files, risk management, and clinical evidence requirements. We have led ISO 13485-aligned programs from early research through to clinical trials.
Australian Standards Compliance
AS/NZS 4760 & 4308
Both standards set specific performance requirements — cut-off concentrations, cross-reactivity panels, stability conditions. We have direct experience designing to these standards from the start and preparing products for RASL-accredited independent testing.
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.

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 an entrepreneur finding that the regulatory environment is more complex than expected — we'd like to hear from you.

Location Remote & On-site
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