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Non-Regulated

Our Non-GXP service carries out analytical tests with data reproducibility and data quality which is able to provide solid proofs to help formulate study plans for IND and clinical trials, and enable planning of supportive diagnostic strategies during new drug research and development.

Capabilities

Exploratory Toxicology Studies

Exploratory Toxicology Studies

Quick turnaround for toxicity assessments, helping you define safe starting doses for subsequent regulated studies.

Pharmacokinetic Analysis

Pharmacokinetic Analysis

Rapid generation of PK data to understand the absorption, distribution, metabolism, and excretion (ADME) properties of your compounds.

Biomarker Analysis

Biomarker Analysis

Early identification and validation of biomarkers for therapeutic targeting and response monitoring.

Custom Assay Development

Custom Assay Development

Development of customized assays tailored to your specific study needs and targets.

Platforms

1

LC-MS/MS

2

ELISA and MSD

3

Cell-based Assays

For sensitive and specific quantification of molecules in complex mixtures.
For PK, PD, ADA, and biomarker screening.
To assess the biological activity and pharmacodynamics of your compounds.

Why Do You Need Non-Regulated Services?

Speed and Efficiency: Quick setup and rapid execution of studies to accelerate your research and development timelines.

Expertise and Experience: Our team of scientists brings extensive experience in bioanalysis, providing insights and support tailored to your project's specific needs.

Quality and Precision: Despite the non-regulated nature of the studies, we adhere to the highest standards of quality and precision, ensuring that your data is reliable and robust.

Innovative Approach: We continuously invest in the latest technologies and methodologies to stay at the forefront of bioanalytical services, offering you advanced solutions.