Reliable analytical methods for the life sciences
An analytical method must be accurate, reproducible and fully compliant with international validation and quality assurance requirements. Normec supports organisations with the development, validation and transfer of analytical methods for pharmaceuticals, medical devices, nutraceuticals and cosmetics.
From our cGMP-certified laboratory, we develop and validate analytical methods that are suitable for both routine quality control and regulatory submissions.
Analytical methods in accordance with ICH guidelines
We develop and optimise analytical methods for a wide range of applications in quality control, product development and validation. Our focus is on delivering reliable, reproducible methods that perform consistently in laboratory and manufacturing environments.
Our services include:
- Method development for APIs, pharmaceuticals and medical devices
- Optimisation of HPLC, GC, LC and MS/MS methods
- Analytical method validation in accordance with ICH guidelines
- Analytical method transfer from in-house laboratories or external contract laboratories
- Development of cleaning validation protocols
- Support for regulatory submissions and audits
All work is carried out in accordance with internationally recognised standards, including USP, EP and ICH guidelines.
Validated methods you can rely on
An analytical method must be proven fit for its intended purpose. That is why we conduct comprehensive validation studies to demonstrate its performance, reliability and reproducibility.
During validation, we assess:
- Method specificity and selectivity
- Linearity across the analytical range
- Limit of Detection (LOD) and Limit of Quantification (LOQ)
- Accuracy and precision
- Robustness and reproducibility
- Suitability for routine quality control
This approach helps organisations achieve regulatory compliance more efficiently, reduce risk and optimise analytical processes.
With our support, you can:
- Demonstrate the reliability of laboratory results
- Strengthen compliance with international regulations and guidelines
- Implement analytical methods more efficiently within quality control processes
- Be fully prepared for audits and inspections
- Increase confidence throughout product development and manufacturing
Cleaning validation and quality assurance
In addition to method development and validation, we support organisations with cleaning validation for manufacturing and packaging processes. We develop dedicated analytical methods and validation protocols to verify the effectiveness of cleaning procedures.
Our specialists provide practical guidance on implementation, risk assessment and regulatory compliance. This helps organisations control contamination risks while maintaining safe and efficient production processes.
Future-ready analytical solutions
With our cGMP-certified laboratory, ISO/IEC 17025 accreditation and extensive knowledge of international regulations, Normec supports organisations in the pharmaceutical, medical device, nutraceutical and cosmetics sectors with reliable analytical solutions.
Together, we develop analytical methods that are ready for the future and meet the highest quality standards.
Would you like to know more about method development and validation?
Frequently Asked Questions
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Analytical method development involves designing and optimising analytical procedures to accurately measure products, raw materials or contaminants.
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Analytical method validation demonstrates that a method is accurate, reproducible and suitable for its intended purpose.
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Method transfer is the controlled process of transferring an established analytical method from one laboratory to another while ensuring consistent performance and compliance with quality and regulatory requirements.
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We support a wide range of analytical techniques, including HPLC, GC, LC and MS/MS.
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Validation demonstrates that analytical results are reliable and helps organisations comply with international regulations and industry guidelines.
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We support organisations in the pharmaceutical, medical device, nutraceutical and cosmetics sectors.
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We work in accordance with internationally recognised standards and guidelines, including USP, EP and ICH.