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Analytical Method Development & Validation
(ICH Q2(R2) + Q14 Ready
- Accelerate product registration with compliant, risk-based analytical procedure development and validation.
- ICH Q2(R2) / Q14 / USP / EP Compliant Process
- GMP, GLP & ISO 17025 Certified
- Clear Deliverables
Food & Beverage Testing
Medical Device Testing
Pharmaceutical Testing
Materials & Packaging Testing
Environmental Testing
Why Choose Us
for Method Development & Validation
Regulatory Compliance
Fully aligned with ICH Q2(R2), Q14, USP, EP, and FDA guidelines.
Certified Expertise
ISO 17025 / GLP certified lab with experienced scientists.
Proven Track Record
1,000+ validated methods supporting global submissions.
Faster Turnaround
Optimized workflows to save time and reduce approval delays.
| Your Challenge | Our Solution |
|---|---|
| 1. Delayed approvals due to non-compliant methods | Risk-based Q14 approach to ensure regulatory readiness and fewer reviewer questions |
| 2. Methods not robust or transferable | Lifecycle-based development with robustness and transfer packages |
| 3. High communication and project management burden | Dedicated project manager + transparent milestone tracking |
| 4. Lack of internal expertise or resources | End-to-end service from concept to submission-ready reports |
Our Services
Comprehensive solutions to support every stage of analytical method lifecycle:
- Method Development: HPLC, UPLC, GC, LC-MS/MS, UV, IR, and more.
- Method Validation: Accuracy, precision, specificity, linearity, LOD/LOQ, robustness, system suitability.
- Stability-Indicating Methods: Forced degradation studies to ensure long-term product quality.
- Impurity Profiling: Identify, quantify, and control impurities.
- Dissolution Testing: Optimize drug release and performance testing.
- Cleaning Validation: Verify cleaning procedures meet regulatory standards.
- Method Transfer & Training: Smooth, compliant transfer between labs or sites.
- Bioanalytical Method Validation: For clinical and biological samples (if applicable).
End-to-end analytical method solutions, including development (HPLC, UPLC, GC, LC-MS/MS), full ICH Q2(R2) validation, stability-indicating methods, impurity profiling, dissolution testing, cleaning validation, method transfer, and bioanalytical validation.
Step-by-Step Process
01. Consultation & Requirements Gathering
Define scope and regulatory needs.
02. Risk Assessment & Design (Q14)
Identify critical parameters and control strategies.
03. Method Development & Optimization
Select technologies and optimize conditions.
04. Validation & Documentation (Q2R2)
Conduct validation per ICH standards.
05. Final Report & Method Transfer
Deliver regulatory-ready documents and training.
What We Offer
Types of Analytical Method Development & Validation Services
Comprehensive solutions for APIs, intermediates, impurities, peptides, biomolecules, and bioanalytical methods.
API / Intermediate / Raw Material Method Development & Validation
Assay / Content Determination Impurity / Related Substance Testing Stability-Indicating Methods / Shelf-Life Testing
Genotoxic Impurities / Trace Impurities Analysis
Limit Test for Trace Impurities Genotoxic Impurities (e.g., mutagenic compounds) Elemental Impurities / Heavy Metal Testing (e.g., ICP-MS)
Small Molecule / Organic Compound Method Development & Validation
HPLC / UPLC / GC / GC-MS Chromatography-Mass Spectrometry Coupling (LC-MS/MS, GC-MS) Non-Chromatographic Methods (e.g., UV, IR, Titration, Direct MS Methods)
Impurity Identification & Structure Elucidation
High-Resolution Mass Spectrometry (HRMS) / MSn Nuclear Magnetic Resonance (NMR) / Spectroscopic Techniques Degradation Product & Metabolite Identification
Peptide / Protein / Biomolecule Method Development & Validation
Peptide Quantification / Purity / Peptide Mapping Protein Content / Binding Assays / Degradation Analysis Quantification of Peptides & Proteins in Biological Samples (e.g., serum, urine)
Dissolution / In Vitro Release Testing
Dosage Form Dissolution Profile Testing In Vitro Release Models Comparative Release Analysis
Cleaning Validation / Residue Analysis
Equipment Residue Detection Manufacturing Process Cleaning Validation Quantification of Residual Solvents & Cleaning Agents
Method Transfer / Method Bridging / Training
Cross-Laboratory / Cross-Equipment Method Transfer Method Comparison & Difference Analysis Recipient Training & SOP Implementation
Bioanalytical Method Development & Validation (If Applicable)
Quantitative Analysis of Plasma, Serum, or Urine Samples LC-MS/MS Bioanalytical Method Validation Antibody & Biologic Molecule Testing
Latest Case Studies
“A pharmaceutical client reduced their regulatory review time by 30% using our stability-indicating method development and Q2R2-compliant validation process.”
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Address
No. 43, Fukang Road, SHENZHEN, CN
Call Us
+86 0755 28502380
Email Us
sales@uhplcs.com