Nitrosamine Testing Services

We offer sensitive and validated analytical methods to detect and quantify nitrosamine impurities in pharmaceutical products. Our testing ensures regulatory compliance and product safety, helping clients meet evolving global standards.

Detection and quantification via LC-MS/MS
Risk assessment aligned with USFDA, EMA, CDSCO
Method development per ICH guidelines
Testing of drug substances/products/excipients
Batch and stability testing
Risk assessment reports & regulatory submissions
Fast turnaround with high sensitivity
Mitigation consultation

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Clinical Trial Management (Phase I - IV) on Patients

Bioavailability & Bioequivalence (BA/BE) Studies

Pharmacovigilance & Safety Services

Regulatory Affairs & Quality Compliance

Medical Writing & Scientific Support

Data Management & Biostatistics

Site & Patient Recruitment Support

Clinical Trial Logistics & Supply Chain

Real-World Evidence & Decentralized Trials

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Nitrosamine Testing Services

We offer sensitive and validated analytical methods to detect and quantify nitrosamine impurities in pharmaceutical products. Our testing ensures regulatory compliance and product safety, helping clients meet evolving global standards.

Explore Services

Inquiry Now!

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