Method Validation – Ensuring Accuracy,
Reliability & Regulatory Compliance
Method validation is a critical process in pharmaceutical analysis to confirm that an analytical method is accurate, precise, specific, reproducible, and robust for its intended purpose. Regulatory bodies such as ICH, USP, EP, and WHO mandate method validation to ensure the credibility of test results used in product development, quality control, and regulatory submissions. At SIMA LABS, we conduct comprehensive method validation for a wide range of analytical techniques, ensuring compliance with ICH Q2(R1) guidelines and global pharmacopeial standards. Our experienced scientists validate methods for APIs, excipients, and finished products, covering parameters like specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and ruggedness.
Why Choose SIMA LABS for Method Validation Testing?
- ICH-Compliant Protocols – Validation performed as per ICH Q2(R1), USP, EP, and WHO guidelines.
- Advanced Instrumentation – HPLC, GC, ICP-MS, UV-Vis, FTIR, and more.
- Wide Scope – Applicable to assay methods, impurity profiling, dissolution, stability, and microbiological methods.
- Experienced Team – Skilled analysts with proven expertise in regulated environments.
- Regulatory Acceptance – Data and reports prepared for domestic and international submissions.
- Customised Validation Plans – Tailored to your product, method, and market requirements.
35+ Years of SIMA LABS – Method Validation Testing You Can Trust
SIMA LABS is NABL accredited and approved under FSSR and BIS for conducting method validation in compliance with ICH Q2(R1), USP, EP, BP, and WHO guidelines. Our validated protocols ensure that analytical methods used for pharmaceutical testing meet the highest standards of accuracy, precision, specificity, and robustness, enabling regulatory acceptance both in India and globally.
We offer complete method validation services to ensure analytical procedures are fit for purpose and deliver reliable, reproducible results.
Scope of Validation:
Applicable To: APIs, excipients, finished dosage forms, intermediates, stability samples, and microbiological methods.
Validation Parameters:
Specificity
Linearity & range
Accuracy & recovery
Precision (repeatability & intermediate precision)
Limit of Detection (LOD) & Limit of Quantitation (LOQ)
Robustness & ruggedness
System suitability testing
Techniques Covered:
HPLC, GC, UV-Vis, FTIR, ICP-MS, ICP-OES
Microbiological & dissolution methods
Regulatory Compliance:
ICH Q2(R1)
USP, EP, BP, JP
WHO technical reports
Our expert team, state-of-the-art instrumentation, and globally accepted protocols ensure your analytical methods are validated to meet both domestic and international regulatory requirements.
Trusted by leading brands
our customers are the driving force behind our growth and innovation
Precision. Compliance. Innovation
Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
Residue Analysis
SIMA LABS offers residue testing and compliance with ELV, RoHS, REACH, and EN71 standards
Microbiological Analysis
SIMA LABS provides microbiological testing and indoor air quality monitoring.
Molecular Biological Analysis
SIMA LABS offers GMO, allergen, pathogen testing, event identification, and pharma analysis for safety and compliance.
Method Development and Validation Studies
SIMA LABS provides stability testing, drug analysis, quality checks, lab consultancy, training, and R&D support.
Environment Monitoring
SIMA LABS offers environmental testing for pollutants, gases, and air quality monitoring.
Get In Touch
At SIMA LABS, we’re proud to offer our expertise in analysis and research to help you find the right solutions.
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+(91)-(11)-43854300