Our Services
Cost-effective, regulatory-compliant testing services helping pharmaceutical and medical device companies overcome unique analytical challenges.
Nitrosamine and NDSRI
Method development, Validation & Analysis
Extractable & Leachable
USP 1663, 1664, ICH, PQRI, ISO 10993
Elemental Impurity Studies
ICHQ3D, Heavy Metals, Residues etc.
Chemical Characterization for Medical Devices
ASTM Methods, EO Residue, ECH Residue etc...
Method Development & Validation
Both Pharma and Medical devices
Genotoxic Impurities Evaluations
Method development, Validation & Analysis
ETO residual testing
ISO 10993-7 Including Method development & Validation
How We Work
Our Process
A structured, transparent engagement from initial consultation to ongoing support.
Consultation
We begin by understanding your product, regulatory landscape, and specific analytical challenges. Our scientists work closely with you to define a clear scope of work and timeline.
Study Design
A detailed analytical plan is developed — tailored to your product matrix, target analytes, and regulatory requirements. Every protocol is reviewed before execution begins.
Sample Analysis
Our team executes validated methods using advanced instrumentation (LC-MS/MS, ICP-MS, GC-MS) under strict GLP conditions, ensuring data integrity at every step.
Validated Report
You receive comprehensive, QA-reviewed documentation that is regulatory-ready — formatted for FDA, EMA, CDSCO, or any other authority your submission requires.
Technical Support
Our relationship doesn't end at delivery. We provide ongoing technical support for regulatory queries, audits, method transfers, and any follow-up studies.
Need Analytical Testing?
Talk to our experts today to discuss your project requirements and timelines.