Analytical Accuracy and GLP Services in Pre-clinical and Clinical Processes

What is the importance of obtaining analytical services in accordance with GLP standards?

Analytical Accuracy in Preclinical and Clinical Processes

The journey of a drug molecule or biotechnological product from the laboratory to the patient requires a high level of responsibility and flawless data accuracy. Data obtained during clinical trial phases shape not only the product’s future but also human health directly. In this critical process, the gold standard for ensuring that analytical results are accepted by international authorities is GLP (Good Laboratory Practices) certification. As the Nanolab Laboratories Group, we serve as your global partner by providing all the analytical services you need for clinical and preclinical studies through our GLP-certified facilities and expert staff.

Why Is It Important to Obtain Analytical Services in Compliance with GLP Standards?

GLP is a quality management system that ensures the planning, conduct, monitoring, recording, archiving, and reporting of laboratory studies. Working with a GLP-compliant laboratory in clinical studies offers you the following advantages:

• Global Validity: National and international health authorities such as the FDA, EMA, and TİTCK require or prioritize that preclinical toxicology and clinical bioavailability/bioanalytical data come from GLP-compliant laboratories.
• Data Integrity: Every stage of the analysis is recorded in a traceable, tamper-proof, and reproducible manner. The margin for error is minimized.
• Time and Cost Savings: It prevents the need to repeat clinical tests due to non-compliant or insufficient documentation, thereby accelerating regulatory approval processes.

Nanolab GLP Analytical Service Scope

With our advanced instrument inventory (LC-MS/MS, HPLC, GC-MS, ICP-MS) and validated methods, we support you at every step of your clinical trials:

1. Bioanalytical Services (Pharmacokinetics and Pharmacodynamics): In clinical phase studies (Phases I–IV), we perform sensitive method validations and routine sample analyses in biological matrices (plasma, serum, urine, etc.) to monitor the drug’s behavior in the human body (PK/PD).
2. Biosimilar and Biotechnological Product Characterization: Structural characterization, purity testing, and activity analyses of biological and biosimilar products—the medicine of the future—are reported in full compliance with GLP guidelines.
3. Stability and Formulation Analyses: We test the long-term stability and formulation accuracy of investigational medicinal products (IMPs) intended for clinical trials using advanced climate-controlled chambers and analytical methods.
4. Impurity and Residue Analyses: We conduct the detection and quantification of trace impurities (elemental impurities, genotoxic impurities, residual solvents) that may originate from the production process at the lowest detection limits (LOD/LOQ).

Why is Nanolab Your Trusted Partner in Clinical Trials?

• Accredited and Approved Infrastructure: Laboratory processes designed in accordance with GLP requirements, qualified instrument validations (IQ/OQ/PQ), and computerized system validations (21 CFR Part 11 compliant).
• Expert and Experienced Staff: Analysts and study directors who are well-versed in clinical trial regulations and documentation requirements.
• Rigorous Quality Assurance (QA) Oversight: Every study project is meticulously monitored step-by-step by our independent Quality Assurance unit and culminates in a GLP Compliance Statement.

Developing an innovative product in the healthcare sector requires a grand vision and significant effort. At Nanolab, we ensure that this effort is supported by the most accurate analytical data during clinical phases. With our GLP-certified analytical services, we provide solutions fully compliant with local and global regulations, shortening your regulatory approval journey.
Contact us for the analytical and bioanalytical needs of your clinical projects and experience reliable results in accordance with GLP standards.

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