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GCLP

Our laboratories comply with global regulatory requirements, generating lab data that are qualified for global IND/NDA filing. Our experts and professionally trained team, along with experienced QA&QC, guarantee the projects meeting highest quality standards worldwide.

GCLP

Clinical Protocol Sample Analysis Plan
Reference Standards & Biological Samples
Test Environment
Sample Analysis
Data Transfer
Report

Comprehensive personneltraining system

Initial qualification training

Refreshing training

Enhancement training

Internal quality control mechanism

Departmental QC

QA inspection : on-site/process/facility external consultant

Enhancement training

Comprehensive SOP system

Test Facility &Quality system

Method Validation

Sample analysis

Material and reagent

Instrument Equipment

External agency inspection

Regulatoryagencies inspection

Clients Inspection

Project Inspection

Test Menu

Pharmacokinetics (PK) Testing

  • Precision analysis to determine the absorption, distribution, metabolism, excretion (ADME) of pharmaceutical compounds
01 /6

Pharmacodynamics (PD) Testing

  • Targeted assays to measure the biological activity of a drug at the tested doses.
02 /6

Immunogenicity Testing

  • Evaluation of the immune response to biologic therapies, crucial for assessing safety and efficacy.
03 /6

Biomarker Testing

  • Identification and validation of biomarkers for disease progression and treatment response.
04 /6

Bioequivalence and Biosimilarity Studies

  • Critical analyses for generic and biosimilar development.
05 /6

Toxicokinetics (TK) Testing

  • Detailed assessment to understand the systemic exposure of test substances and their metabolites.
06 /6

Why Do You Need GCLP Services?

Expertise in GCLP Compliance: Our laboratory operates under Good Clinical Laboratory Practice (GCLP) guidelines, ensuring that all analytical work is performed with high standards of quality and compliance. Our team is regularly trained and audited to maintain and exceed these standards.

Advanced Analytical Technologies: We employ state-of-the-art analytical equipment and methodologies, including LC-MS/MS, ELISA, and cell-based assays, to provide accurate, reliable, and reproducible results across a wide range of sample types and therapeutic areas.

Customized Solutions: We understand that each study is unique. Our experienced scientists work closely with clients to develop customized testing strategies that meet the specific needs of their clinical trials.

Rapid Turnaround Times: Our optimized processes and dedicated team ensure that we meet tight deadlines, helping you stay on track with your clinical timelines.