NABL Accredited CDSCO Approved USFDA Inspected (Manesar & Bangalore)

Analytical Method Development and Validation | ICH Q2(R2) and Q14 | NABL | Auriga Research

Analytical method development and validation is the regulatory backbone of every pharmaceutical testing programme. Every method used for release testing, stability studies, impurity profiling, or dossier submission must be demonstrated as fit for purpose under a current ICH framework. Auriga Research provides end-to-end method development and validation services against the current active framework: ICH Q2(R2) — Validation of Analytical Procedures (March 2024) and ICH Q14 — Analytical Procedure Development (2023). Q2(R2) replaces Q2(R1) and modernises the validation framework; Q14 is the companion development-side guideline formalising the analytical procedure lifecycle.

Method development per ICH Q14 begins with systematic technique selection and feasibility assessment, followed by column and mobile-phase screening, optimisation of separation conditions, and forced-degradation studies to establish stability-indicating capability. Once the method is optimised, the team executes full ICH Q2(R2) validation covering specificity, linearity, range, accuracy, precision (repeatability and intermediate precision), LOD, LOQ, robustness, and system suitability — with detailed protocol, raw data, and validation report suitable for inclusion in CTD Module 3.

Method development and validation is anchored at Manesar (Plot 136, Sector 5, IMT Manesar) — the USFDA Inspected facility — with companion capability at Delhi HQ (Arbro Analytical Division) and Bangalore (USFDA Inspected). Method transfer to Baddi and Bahadurgarh is supported for production-scale routine testing. Methods cover HPLC, UPLC, LC-MS/MS, GC, GC-MS, dissolution, UV-Vis, Karl Fischer, ICP-OES, and ICP-MS platforms. NABL-accredited (ISO/IEC 17025:2017) validation reports are accepted by CDSCO, USFDA, EMA, and PMDA without re-testing.

ICH Q2(R2) + Q14 — the Current Active Framework

ICH Q2(R2) (Validation of Analytical Procedures, March 2024) replaces Q2(R1) and modernises the validation framework. ICH Q14 (Analytical Procedure Development, 2023) is the companion development-side guideline formalising the analytical-procedure lifecycle. All Auriga method packages are built against the Q2(R2) + Q14 framework — documentation formatted for direct CTD Module 3 inclusion. Submissions still referencing Q2(R1) should be updated to Q2(R2) before filing.

Method development 2 to 4 weeks | Q2(R2) validation 3 to 4 weeks | Combined 6 to 8 weeks

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Six Method Development & Validation Services

Each card maps the service to the governing ICH guideline, the analytical technique, and the Auriga lab where it is performed.

Q14 Dev

Method Development per ICH Q14

HPLC, LC-MS/MS, and GC method development per ICH Q14 (2023) using systematic technique selection, column and mobile-phase screening, and risk-based optimisation. Manesar, Delhi, and Bangalore.

Q2(R2) Val

Full Method Validation per ICH Q2(R2)

Full ICH Q2(R2) validation package: specificity, linearity, accuracy, precision (repeatability + IP), LOD, LOQ, and robustness with deliberate variation of critical method parameters. Manesar (USFDA Inspected).

AMV

Abbreviated Method Validation

Abbreviated method validation (AMV) for compendial method adaptations and pharmacopoeial method verification per USP, IP, EP, and BP general chapters. Faster turnaround than full validation.

Transfer

Method Transfer with Equivalence Verification

Method transfer between Auriga labs or from client site, with formal equivalence verification protocol covering co-validation, comparative testing, and parallel-run analysis.

Forced Deg

Forced Degradation & Stress Testing

Forced degradation studies per ICH Q1 series and ICH Q2(R2) — acid, base, oxidative, photolytic, and thermal stress to confirm stability-indicating capability of the method.

Revalidation

Revalidation after Method Change or Transfer

Partial revalidation following changes to method parameters, equipment, column lot, or laboratory site. Scope per ICH Q2(R2) Section 5 revalidation triggers and the analytical lifecycle.

Project Timelines

Indicative TAT from project kick-off at Manesar. Confirm exact timeline with your SPOC at quote stage based on analyte complexity, matrix, and validation scope.

Service Type	Turnaround Time
Method Development (ICH Q14)	2 to 4 weeks
Full Method Validation (ICH Q2(R2))	3 to 4 weeks
Combined Development + Validation	6 to 8 weeks
Abbreviated Method Validation (compendial)	2 to 3 weeks
Method Transfer with Equivalence	2 to 3 weeks
Revalidation after Method Change	2 to 4 weeks

How It Works

Get a Quote

Share your analyte, matrix, regulatory authority, and dossier type. Indicate whether you need development from scratch, validation of a draft method, or AMV. Your SPOC confirms lab, instrument, and scope.

Collect and Send Your Sample

Prepare sample per SPOC instructions at quote stage. Each sample is bar coded and registered in YLIMS on receipt.

Testing and QA Review

Your sample is tested under NABL-accredited conditions. Results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.

Receive Your NABL Report

Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.

Who Needs Method Development & Validation

Pharma manufacturers requiring validated analytical methods for CDSCO or USFDA dossier submission.
Generic developers needing method development and validation for ANDA submissions and CDSCO product approvals.
CDMO clients requiring method handover as part of formulation handover, scale-up, or technology transfer.
API manufacturers requiring methods to support ICH Q3A(R2) and Q3B(R2) impurity reporting in the DMF.
Stability teams requiring stability-indicating methods proven by ICH Q1-aligned forced degradation studies.
QC labs running compendial methods that need ICH Q2(R2) abbreviated validation (AMV) for site verification.
Companies transferring established methods between Auriga labs (Manesar to Delhi, Bangalore, Baddi, Bahadurgarh) for production routine testing.
Regulatory affairs teams compiling CTD Module 3 analytical method sections under the current Q2(R2) + Q14 framework.

Why Auriga for Method Development & Validation

110+ HPLC and UPLC Systems Across 5 Labs

Method development without instrument-availability delays. 110+ HPLC and UPLC systems across the 5-lab network, with 605 chromatography columns in active stock for rapid column-screening iteration.

Manesar — the USFDA Inspected Anchor

Method development and full validation anchored at Manesar — the USFDA Inspected facility. Validated method packages accepted in USFDA dossiers without re-testing.

ICH Q2(R2) + Q14 Compliant Documentation

Method packages built against the current Q2(R2) (March 2024) + Q14 (2023) framework. Documentation formatted for direct CDSCO, USFDA, and EMA Module 3 inclusion.

Method Transfer Across the Lab Network

Formal equivalence verification protocol for method transfer between Manesar, Delhi, Bangalore, Baddi, and Bahadurgarh. Co-validation and parallel-run analysis supported.

Multi-Platform: HPLC, LC-MS/MS, GC, ICP-MS, Microbiology

Method development and validation across all major techniques in one organisation. No need to split between dedicated method-dev vendors for different platforms.

Stability-Indicating Forced Degradation

Forced degradation per ICH Q1 series — acid, base, oxidative, photolytic, thermal — to establish stability-indicating capability before validation. Standard part of the development package.

NABL Accredited Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group · Auriga Research

Regulatory References

• ICH Q2(R2) — Validation of Analytical Procedures (March 2024). Current active framework.
• ICH Q14 — Analytical Procedure Development (2023). Companion to Q2(R2).
• ICH Q1 series — Stability framework for forced-degradation stress conditions.
• ICH Q3A(R2) / Q3B(R2) — Impurity thresholds informing method scope and LOD/LOQ targets.
• ICH Q3D(R2) — Elemental impurities (for ICP-MS method development and validation).
• USP, IP, EP, BP, JP — Pharmacopoeial general chapters for compendial method verification (AMV).

Related Services

Frequently Asked Questions

Which ICH guidelines govern analytical method development and validation today?

The current active framework is ICH Q2(R2) — Validation of Analytical Procedures, published March 2024 — and ICH Q14 — Analytical Procedure Development, published 2023. Q2(R2) replaces Q2(R1) and modernises the validation framework. Q14 is the companion development-side guideline introduced to formalise the analytical procedure lifecycle. Auriga method packages are built against the Q2(R2) + Q14 framework with documentation formatted for direct CTD Module 3 inclusion.

What does an ICH Q2(R2) validation package cover?

A full ICH Q2(R2) validation package evaluates specificity (with forced-degradation stability-indicating proof), linearity and range (correlation, intercept, residuals), accuracy and recovery (80/100/120 percent of target), precision (repeatability intra-day and intermediate precision inter-day or inter-analyst), limit of detection (LOD) and limit of quantitation (LOQ), robustness (deliberate variation of critical method parameters), and system suitability. The package includes a written protocol, raw data, validation report, and traceability documentation suitable for CDSCO, USFDA, EMA, and PMDA submissions.

What analytical techniques does Auriga develop and validate methods for?

Auriga develops and validates methods across all major pharmaceutical analytical techniques: HPLC and UPLC with UV / PDA / RI / fluorescence detection, LC-MS/MS for impurity and nitrosamine work, GC and GC-MS / GC-MS/MS, GC headspace for residual solvents, dissolution testing per USP 711, UV-Vis spectrophotometry, Karl Fischer titration, ICP-OES and ICP-MS for elemental impurities per ICH Q3D(R2), and microbiological assay platforms. The team selects the appropriate technique based on the analyte, matrix, and regulatory purpose, then develops the method per ICH Q14 and validates per ICH Q2(R2).

What is the difference between method development and method validation?

Method development per ICH Q14 is the process of designing and optimising an analytical procedure — selecting the technique, column, mobile phase, detection parameters, and sample preparation — using a systematic risk-based and lifecycle approach. Method validation per ICH Q2(R2) is the subsequent process of proving that the developed method performs as intended, meeting predefined acceptance criteria for specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and system suitability. Development precedes validation, and both are required for regulatory acceptance.

Which Auriga lab performs method development and validation?

Method development and validation is anchored at Manesar (Plot 136, Sector 5, IMT Manesar) — the USFDA Inspected facility — with companion capability at Delhi HQ (Arbro Analytical Division) and Bangalore (USFDA Inspected). Method transfer to Baddi and Bahadurgarh is supported for production-scale routine testing. NABL-accredited (ISO/IEC 17025:2017) validation reports are accepted by CDSCO, USFDA, EMA, and PMDA without re-testing.

What is the typical turnaround time for method development and validation?

Method development per ICH Q14 typically requires 2 to 4 weeks depending on analyte complexity and matrix. Full ICH Q2(R2) method validation requires 3 to 4 weeks. Combined development plus validation projects are completed within 6 to 8 weeks. Abbreviated method validation (AMV) for compendial method adaptations is completed in 2 to 3 weeks. Method transfer with equivalence verification: 2 to 3 weeks. Revalidation after method change or transfer: 2 to 4 weeks.

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