Testing and release for pharma and life sciences
Analytical method development and validation
We offer comprehensive analytical method development and validation services for the pharmaceutical, medical device, and life sciences industries. These services are essential to ensure that the analytical methods used for testing raw materials, intermediates, and finished products are both reliable and compliant with international regulatory standards.
Our cGMP-certified laboratories, experienced team, and systematic approach ensure that your methods are scientifically sound, well-documented, and ready for use in a compliant environment.
Why choose us?
cGMP-accredited and ISO 13485-certified laboratory
Testing aligned with USP, EP, and ICH Q3D
Fast turnaround and expert support
In-house QA team ensures compliance and reliability
Flexible solutions tailored to your needs
From Development to Validation: A Seamless Process
Method development is the first critical step. A poorly developed method can lead to unreliable results, rework, and regulatory delays. That’s why our team uses a structured, step-by-step process to design and optimise methods that are robust, reproducible, and aligned with the intended use.
We develop methods for:
Drug products
Active Pharmaceutical Ingredients (APIs)
Excipients and raw materials
Medical devices
Healthcare and cosmetic products
To support the development of stability-indicating methods, we also perform forced degradation studies — including exposure to acid, base, oxidation (peroxide), light, and elevated temperature.
Once a method has been successfully developed, we proceed to method validation. This step confirms that the method performs reliably under defined conditions. All our validations are conducted according to the ICH Q2(R1) guidelines, ensuring international acceptability.
Before each validation, we draft a method validation protocol in close consultation with you. Once approved, we carry out the full validation, assessing critical parameters such as:
Specificity
Limit of detection (LOD) and limit of quantification (LOQ)
Linearity
Accuracy
Precision
Robustness
The results are presented in a clear and complete validation report, ready for internal use or submission to regulatory authorities.
Cleaning Validation
In addition to analytical method validations, we also conduct cleaning validation studies. These are vital for ensuring that no cross-contamination occurs between production batches — especially in pharmaceutical manufacturing and packaging processes.
We help you demonstrate that your cleaning procedures are effective and that residues are within acceptable limits, using sensitive and validated methods.
Analytical Method Transfer
When introducing a new method into a different laboratory, a method transfer is often required. We support full and partial method transfers, ensuring compliance with regulatory expectations and a smooth transition.
Together, we determine the most suitable transfer model and carry out the necessary verification steps to qualify our lab for the method — always within the applicable regulatory framework.
These services might also be of interest to you
Pharmaceutical quality control testing
Elemental impurities testing
Method Transfer
Leading companies in this service
Normec Synergy Health
Nieuwegein Netherlands