Bioanalytical Services

Precision Bioanalytical Solutions for Drug Development.

We at Aizant, specialized in providing quality bioanalytical services that support the development of Generics, Complex Generics, New Chemical Entities (NCEs) and New Drug Applications (NDAs). Our experts confirm the highest level of accuracy and reliability in every analysis and are committed to delivering regulatory-compliant results that accelerate product’s development and market approval.

Comprehensive Bioanalytical Services

Feasibility Evaluation and Method
Development

Before initiating a trial, we provide detailed feasibility evaluations based on literature support and project requirements. Our team develops fit-for-purpose methods to handle the complexity of different compounds and formulations.

Clinical Sample Analysis

We offer robust LC-MS/MS analysis with 18 instruments, supporting clinical studies from early-phase to large-scale trials. Our expertise includes complex small molecule assays (e.g., chiral compounds, pro-drugs, and unstable metabolites) and large molecule analysis (e.g., peptides, proteins, and multi-analyte assays), with quick turnaround times for sample processing and results.

Regulatory-Grade Bioanalysis

Bioanalytical methods are developed and validated in strict compliance with global regulatory guidelines. Whether supporting IND-enabling studies, clinical trials, or final regulatory submissions, we deliver timely and accurate results that adhere to the highest industry standards.

Centralized Lab Services

Equipped with state-of-the-art instruments such as the API 5500, 4500, 4000, Xevo TQS, and ICP-MS systems, our bioanalytical infrastructure is capable of handling sensitive assays for a broad range of compounds, including hormones, vitamins, liposomal formulations, and other critical analytes.

Metal Analysis

With two Agilent 7850 ICP-MS systems, we specialize in metal analysis, providing highly sensitive detection of trace metals in biological samples.

Our Key Capabilities

  • More than 500 methods validated to meet global regulatory standards.
  • Expertise in developing sensitive methods for Generics, Complex Generics NCEs and NDAs with low detection limits.
  • Specialized in developing bioanalytical methods with lower limits of quantification (LLOQ) down to 1pg/mL.
  • Equipped with state-of-the-art LC-MS/MS instruments, including the latest AB SCIEX 6500+, 5500, 4500, 4000, and 3200 systems, along with two ICP-MS (Agilent) instruments and multiple deep freezers ranging from -25°C to -80°C for the secure storage of biological samples.

Move your product forward with confidence.
Get in touch with our bioanalytical experts.