Advanced clinical bioanalysis services for all phases of drug development
Our integrated bioanalytical services support clients from nonclinical and all phases of clinical trials, ensuring precise and efficient analysis throughout product development. We utilize the latest technology for analyzing small and large molecules by following strict quality assurance measures.
From method development and validation to clinical analysis and support services, we offer advanced technologies, regulatory knowledge, and a deep understanding of the entire drug development process, trends, and advancements.
With our efficient logistics, sample management and advanced analytical techniques in place, we ensure on time delivery in full (OTIF), accuracy of data, and reduced cost of your clinical development programs.
One Stop Solutions for Regulatory Bioanalysis
Effective Transition from Preclinical to Clinical: Saving Costs, Time, and Resource
Service Portfolio
Method development Validation & Sample analysis as per Relevant Regulatory Guidelines
Pharmacokinetics
- Quantitation of therapeutics using LC-MS/MS, Ligand Binding Assays - ELISA/ ECL methods
Immunogenicity (Screening, Confirmatory, Titers, Nab titers)
- Quantitative immunoassays using ELISA/ ECL (MSD)
- Cell based Neutralization assays
- Quantification of Nabs by flow cytometry
Biomarkers Analysis
- Detection of Cytokines and inflammatory biomarkers by Flow cytometry / ELISA
- Detection of Biomarkers by ECL (MSD)/ ELISA/ LC-MS/MS.
Therapeutic Drug monitoring
- Quantify drug and ADA levels in patients using above techniques
Bioanalytical Sample Management & Logistics
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Shipment
- Sample shipment through global courier services
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Storage
- Dedicated custodians to receive and handle samples
- In-house sample tracking systems
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Archiving
- Dedicated archivist and freezers for archiving of Samples
Equipments
Multiplate Readers - Agilent
MSD - Qickplex SQ120
SCIEX Triple Quad 4500
Agilent UHPLC systems
BD FACSVerse flow cytometer
QuantStudioTM RT-PCR
Automated Washers
Heidolph Plate incubator shake
State-of-art validated Instruments for high precision sample analysis
