NABL Accredited · R&D Analytical Services

Analytical Development Services India | Method Development | NABL

Analytical development and method development services from an NABL-accredited pharmaceutical laboratory in India.

Analytical development is the foundation of pharmaceutical quality — every release test, stability study, and regulatory submission depends on well-designed analytical methods. Auriga Research provides end-to-end analytical development services, creating fit-for-purpose methods that evolve with your drug development programme from early feasibility through commercial registration.

Our analytical development team works across all major pharmaceutical techniques — HPLC, UPLC, GC, GC-MS, LC-MS/MS, UV-Vis, FTIR, dissolution, Karl Fischer, and ICP — to develop methods tailored to your analyte, matrix, and regulatory requirements. Each development programme includes systematic technique evaluation, column and condition screening, forced degradation studies for stability-indicating capability, and preliminary qualification to demonstrate the method is ready for formal ICH Q2(R1) validation.

We support analytical development for APIs, intermediates, finished products, cleaning validation, extractables and leachables, and bioanalytical applications. Our deliverables include optimised method parameters, development reports with scientific rationale, forced degradation data, and draft validation protocols.

Analytical Development Capabilities

  • HPLC and UPLC method development with systematic column and solvent screening
  • Stability-indicating method development with comprehensive forced degradation
  • GC and GC-MS method development for residual solvents and volatile impurities
  • LC-MS/MS method development for trace-level impurity and bioanalytical applications
  • Dissolution method development for oral solid dosage forms
  • Cleaning validation analytical method development
  • Extractables and leachables method development
  • Method transfer and technology transfer support

Turnaround Time

Simple Method Development: 2-3 weeks
Stability-Indicating Method: 3-5 weeks
Complex Multi-Analyte Method: 4-8 weeks
Development + Validation Package: 6-10 weeks

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Frequently Asked Questions — Analytical Development

What is analytical development in pharmaceutical R&D?
Analytical development is the process of creating, optimising, and qualifying analytical methods that support drug development from discovery through commercialisation. It encompasses method feasibility assessment, technique selection, method optimisation, forced degradation studies, preliminary qualification, and transfer to quality control. Analytical development ensures that reliable methods are available at each stage of the drug development lifecycle.
How does analytical development differ from method validation?
Analytical development is the creative, exploratory phase where methods are designed and optimised for a specific analytical challenge. Method validation is the formal, protocol-driven demonstration that a developed method meets predefined acceptance criteria per ICH Q2(R1). Development precedes validation — you develop a method first, then validate it. Auriga Research provides both services, either sequentially or as standalone engagements.
What is the turnaround time for analytical development projects?
Analytical development timelines depend on project complexity. Simple method development for a single analyte in a straightforward matrix typically requires 2-3 weeks. Complex multi-analyte methods, stability-indicating methods with forced degradation, or methods requiring high sensitivity (ppb-level) may require 4-8 weeks. We provide detailed project timelines during the proposal stage.

Need Analytical Method Development for Your Drug Programme?

NABL-accredited analytical development laboratory. Expert method design across HPLC, GC, LC-MS, dissolution, and more.

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