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Analytical Testing
Regulatory-focused analytical testing supporting product quality, impurity detection, stability evaluation, and compliant pharmaceutical development.
About Analytical Testing
PLS Analytical delivers advanced analytical testing support through experienced scientists, chemists, and modern laboratory instrumentation designed for regulated pharmaceutical and healthcare products. Our analytical capabilities support impurity characterization, method development, product evaluation, stability assessment, and quality-focused investigations through validated analytical environments and data-driven processes.
Operating within cGMP-aligned and regulatory-focused environments, we generate reliable, traceable, and submission-ready analytical data to support product quality, compliance, process understanding, and confident decision-making across development and manufacturing stages.
Why it matters?
Analytical testing is essential for detecting impurities, verifying product quality, and maintaining consistency throughout the product lifecycle. It also helps reduce risk, support regulatory readiness, and ensure that products meet established safety and performance expectations.
Testing Types
Scientific testing services designed to support reliable and compliant products
Method Development
Tailored analytical methods developed around specific products, formulations, and testing requirements.
Method Validation / Verification
Analytical methods evaluated for accuracy, precision, reliability, and suitability against regulatory expectations.
Method Transfer
Seamless transfer of validated analytical methods between laboratories while maintaining consistency and reproducibility.
cUSP Compendial Monograph
Compendial testing performed in line with applicable USP monographs and pharmacopeial requirements.
Nitrosamine Impurity (NDSRI)
Trace-level analysis of nitrosamine impurities and nitrosamine drug substance-related impurities.
Extractables & Leachables
Evaluation of compounds that may migrate from packaging systems, delivery devices, or manufacturing components into pharmaceutical products.
Elemental Impurity
Assessment of elemental and metal contaminants to support product safety and regulatory compliance.
Particle Size Distribution
Particle size analysis performed to assess formulation consistency, delivery behavior, and product performance.
Key Advantages
At PLS Analytical, testing is performed in a GMP-compliant laboratory using advanced analytical techniques and validated methods to generate reliable, data-driven results.
Regulatory-focused testing
Testing approaches aligned with FDA, USP, ICH, and global regulatory expectations to support audits, submissions, and product approvals.
Reliable & data-driven results
Quality-driven analytical workflows are designed to deliver accurate, reproducible, and defensible analytical data.
Support across the product lifecycle
Resources
Explore our insights and successes
Contact Us
Let’s explore the right support for your product
Connect with our team for reliable scientific and regulatory-focused testing support.
Address
40E Cotters Lane, Suite A, East Brunswick, NJ-08816
Telephone
+1 (732) 698-5050Our Methods
Robust testing services for transformative outcomes
