Not every product can be found in the pharmacopoeia.
New compounds, complex matrices, unusual formulations, innovative food ingredients—for many of the products our clients develop or manufacture, a validated analytical method simply does not exist yet. Without such a method, there is no reliable way to measure quality, confirm identity, quantify impurities, or comply with laws and regulations.
Method development is therefore relevant within every sector we serve.
Method development is not a matter of trial and error.
Building a reliable analytical method requires systematic scientific thinking, a deep understanding of the matrix, and the ability to foresee how the method will perform under real-world conditions, not just on a good day in the laboratory.
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Matrix complexity
The product matrix determines everything. A method that works for a pure compound will fail in a complex formulation. We design for the actual matrix from day one, not for an idealized version of it.
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Regulatory expectations
A method that cannot be validated is a method that cannot be used. We build from the start with ICH Q2(R1) validation in mind: specificity, linearity, accuracy, precision, range, and robustness.
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Transfer & reproducibility
A method must work not only in our hands, but also when transferred to another laboratory or used for routine analysis over many years. We design for reproducibility, not just for a one-off result.
Expertise
Reliability
Flexibility
Partnership
From analytical challenge to validated method.
Every method development project at Brightlabs follows a structured workflow, from understanding the analytical challenge to delivering a fully validated, transferable method.
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Defining the analytical goal
What exactly do you need to measure, in which matrix, at what concentration, and with what level of certainty? We start by precisely defining the question, because a vague question leads to a vague method.
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Selecting and optimizing the technique
Based on the target compound, the matrix, and the required sensitivity, we select the most appropriate technique (HPLC, GC, LC-MS, ICP-MS) and optimize the conditions: column, mobile phase, gradient, and detection parameters.
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Developing and stress-testing the method
We test the method against extreme scenarios, including matrix interference, degraded samples, and extreme concentrations, to ensure it performs reliably under conditions that go beyond the ideal.
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Validation according to ICH standards
Full validation in accordance with ICH Q2(R1): specificity, linearity, accuracy, precision, range, limits of detection and quantification, and robustness. Fully documented and audit-ready.
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Documentation and transfer
We provide a complete method package: the validated protocol, documentation, SOPs, and, where necessary, support for transferring the method to your own QC laboratory or a third party.
Sectoren waar methodeontwikkeling essentieel is.
Insights from our laboratory
The complete overview of what Brightlabs does.
Download our brochure for a complete overview of our analytical capabilities, services, and scientific approach.
