GET IN TOUCH

Advanced clinical bioanalysis services for all phases of drug development

img

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.

Logistics, sample management and analytical workflows support timely analysis and data reporting based on study requirements.

One Stop Solutions for Regulatory Bioanalysis

img

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.

Immunogenicity (Screening, Confirmatory, Titers, Nab titers)

  • Quantitative immunoassays using ELISA/ ECL (MSD)
  • Cell based Neutralization assays
  • Quantification of Nabs by flow cytometry

Therapeutic Drug monitoring

  • Quantify drug and ADA levels in patients using above techniques
Bioanalytical Sample Management & Logistics
Shipment
  • Sample shipment through global courier services
Storage
  • Dedicated custodians to receive and handle samples
  • In-house sample tracking systems
Archiving
  • Dedicated archivist and freezers for archiving of Samples
Equipments