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Pharma Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Analytical Method Development & Validation

Stability-indicating, residual solvent, dissolution, and cleaning validation methods per ICH/FDA/USP guidelines.

ICH Q2ValidationAMDAMV
Turnaround Time15–30 working days
DeliverableMethod + Validation Report
Regulatory AcceptanceUSFDA, EU, ICH
Parameters CoveredAll ICH Q2(R1) parameters
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Our Analytical Method Development and Validation (AMD & AMV) services provide scientifically sound, regulatory-compliant analytical methods for pharmaceutical and chemical applications. We develop stability-indicating HPLC methods, GC methods for residual solvents, dissolution methods, and cleaning validation methods, followed by full ICH Q2(R1) validation.

Compendial Standards & Regulatory Alignment:
✓ ICH Q2(R1)✓ ICH Q2(R2)✓ FDA Guidance✓ USP <1225>✓ USP <1226>
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Turnaround Time15–30 working days
DeliverableMethod + Validation Report
Regulatory AcceptanceUSFDA, EU, ICH
Parameters CoveredAll ICH Q2(R1) parameters
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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Stability-indicating HPLC method developmentExecuted with validated SOPs and full raw data audit trails.
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Specificity, linearity, range, accuracy, precisionExecuted with validated SOPs and full raw data audit trails.
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LOD and LOQ determinationExecuted with validated SOPs and full raw data audit trails.
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Robustness and ruggedness testingExecuted with validated SOPs and full raw data audit trails.
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Forced degradation studiesExecuted with validated SOPs and full raw data audit trails.
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Dissolution method development (USP I/II/IV)Executed with validated SOPs and full raw data audit trails.
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Residual solvent method by headspace GCExecuted with validated SOPs and full raw data audit trails.
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Cleaning validation method developmentExecuted with validated SOPs and full raw data audit trails.
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Method transfer protocolsExecuted with validated SOPs and full raw data audit trails.
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Full validation summary reportExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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HPLC (UV/PDA/FLD/RI)

Method development and validation for assay, RS

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-FID with Headspace

Residual solvent method development

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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LCMS/MS

Trace-level impurity method development

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Dissolution Apparatus USP I/II

Dissolution method development

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Feasibility & Literature Review

Review of existing methods, regulatory guidance, and molecule characteristics.

02
Stage 02

Method Development

Systematic optimization of chromatographic conditions, mobile phase, and detection.

03
Stage 03

Validation Execution

All ICH Q2(R1) parameters tested with pre-approved validation protocol.

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Stage 04

Validation Report

Comprehensive validation report with all data, acceptance criteria, and conclusions.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 15–30 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Analytical Method Development & Validation Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
Cross-Discipline Solutions

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ICH-compliant long-term, accelerated, and stressed stability studies with 24/7 monitored climatic chambers.

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Cleaning Method Validation

Validation that equipment is free from API residues and detergents between production batches, as per FDA cGMP guidelines.

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