Analytical Method Development and Validation Services
Ensuring Accuracy, Precision, and Compliance in Pharmaceutical Testing
In the ever-evolving pharmaceutical landscape, analytical method development and validation form the foundation of drug quality assurance. These processes ensure that every analytical test accurately characterizes a drug’s composition, potency, and purity while maintaining compliance with stringent FDA, ICH, and EMA regulations.
At Topiox Research, based in Navi Mumbai, India, we offer comprehensive method development and validation services tailored to the needs of pharmaceuticals, biopharmaceuticals, and complex formulations. With deep expertise in HPLC, LC-MS/MS, and analytical chemistry, our team develops robust, reliable, and regulatory-compliant methods for product development, stability studies, and market submissions.
What Is Analytical Method Development and Validation?
Method Development
Method development involves designing and optimizing analytical procedures that detect, identify, quantify, or test the stability of active pharmaceutical ingredients (APIs) and impurities within drug formulations.
Method Validation
Validation confirms that these analytical methods are accurate, precise, and reproducible across different laboratories and operators. This step ensures that analytical methods perform reliably in accordance with ICH Q2(R2) and FDA guidelines.
Together, method development and validation ensure data integrity, regulatory acceptance, and product consistency across the drug lifecycle.
Scope of Our Analytical Method Development and Validation Services
HPLC Method Development and Validation
Our HPLC (High-Performance Liquid Chromatography) services deliver precise qualitative and quantitative analysis of APIs, impurities, and degradation products.
Reverse Phase & Normal Phase HPLC
Gradient and Isocratic Elution
Forced Degradation & Stability-Indicating Method Development
Validation Parameters: Accuracy, Precision, Linearity, LOD/LOQ, Robustness
LC-MS/MS Method Development and Validation
For trace-level detection and complex matrix analysis, our LC-MS/MS services provide unmatched sensitivity and selectivity.
Quantification of impurities and degradation products
Structural elucidation and metabolite profiling
Bioanalytical method development for pharmacokinetic studies
FDA and EMA-compliant documentation
Stability-Indicating Method Development
We design stability-indicating analytical methods to detect degradation pathways under stress conditions such as thermal, oxidative, photolytic, and hydrolytic environments, following ICH Q1A(R2) standards.
Analytical Method Transfer and Verification
Our scientists perform method transfer, re-validation, and verification across manufacturing, QC, and R&D facilities to ensure consistency and audit readiness.
Custom Analytical Solutions
From ophthalmic products to semi-solid formulations and novel drug delivery systems (NDDS), we provide customized Analytical Testing solutions that meet the most challenging analytical requirements.
Analytical Techniques We Use
Analytical Platform | Application | Regulatory Alignment |
HPLC / UPLC | Assay, Impurity Profiling, Stability Studies | ICH Q2(R2), USP <621> |
LC-MS/MS | Trace Analysis, Structural Confirmation | FDA, EMA |
GC / GC-MS | Volatile Impurity Profiling | ICH Q3C |
UV/Vis Spectroscopy | Dissolution, Drug Release | USP <857> |
FTIR & DSC | Functional Group and Thermal Analysis | ICH Q6A |
Our analytical method development and validation strictly comply with:
- ICH Q2(R2): Validation of Analytical Procedures
- FDA Guidance for Industry (2022): Analytical Procedures and Method Validation
- USP <1225>: Validation of Compendial Procedures
- EMA Guidelines on Analytical Method Validation
- Accuracy – Closeness of measured results to true values
- Precision – Repeatability and reproducibility
- Specificity – Ability to measure analyte without interference
- Linearity & Range – Correlation between concentration and response
- LOD & LOQ – Sensitivity and detection limits
- Robustness & Ruggedness – Reliability under small variations
All Topiox Research validation reports are FDA, EMA, and CDSCO audit-ready, ensuring global regulatory acceptance.
- Pharmaceutical and Biopharmaceutical Development
- Stability and Forced Degradation Studies
- Quality Control (QC) Testing
- API and Raw Material Characterization
- Bioanalytical and Pharmacokinetic Studies
Regulatory Submissions (ANDA, NDA, DMF)
Why Choose Topiox Research for Method Development & Validation?
Regulatory Compliance
Our methods are developed and validated in full alignment with ICH Q2(R2), FDA, and EMA standards.
Expert Analytical Scientists
Our team comprises seasoned chemists with deep expertise in HPLC, LC-MS/MS, GC, and spectroscopic methods.
Advanced Infrastructure
Our Navi Mumbai facility is equipped with cutting-edge chromatographic and spectroscopic instruments for high-precision analysis.
Custom Method Design
Every analytical method is tailored to your drug formulation, matrix, and regulatory requirements.
Comprehensive Reporting
We provide detailed validation reports, including chromatograms, system suitability, method performance data, and SOPs for implementation.
Location Advantage
Located in Navi Mumbai, India, we serve domestic and international pharmaceutical partners, ensuring timely support and regulatory alignment.
Frequently Asked Questions (FAQs)
It’s the process of designing and confirming analytical procedures that consistently deliver accurate, precise, and reproducible results for drug analysis.
The FDA (2022) and ICH Q2(R2) define parameters such as accuracy, precision, specificity, linearity, LOD/LOQ, and robustness for analytical validation.
HPLC ensures accurate identification and quantification of APIs and impurities, playing a crucial role in product purity and stability testing.
LC-MS/MS combines liquid chromatography with mass spectrometry to identify trace impurities and metabolites, especially useful in biopharmaceuticals.
Timelines typically range from 2 to 6 weeks, depending on the complexity of the compound and regulatory requirements.
Yes, we conduct method transfer, verification, and re-validation to ensure consistency across sites and compliance with audit standards.
Contact Topiox Research for analytical method development and validation requirements
A robust analytical method is the backbone of pharmaceutical quality control and regulatory success.
At Topiox Research, we combine scientific precision, regulatory expertise, and cutting-edge technology to deliver FDA- and ICH-compliant method development and validation services in Navi Mumbai, India.Partner with us to ensure that your analytical methods are accurate, reliable, and regulatory-ready empowering your path to compliant, high-quality pharmaceutical products. Contact Topiox Research today to discuss your analytical method development and