All Services
The Challenge:
Every pharmaceutical product requires validated analytical methods to ensure consistent quality. Without robust, compliant methods, your regulatory submissions face delays, rejections, or costly re-work.
Our Approach:
CLS provides comprehensive analytical method development, verification, transfer, and validation services for pharmaceutical APIs and medical devices. All work is conducted per regulatory guidelines, ensuring your methods are accepted by global regulatory bodies.
Why It Matters
ICH compliant validation protocols
Methods accepted by global regulators
Faster regulatory approvals
Transferable methods for commercial manufacturing
Applications
- Pharmaceutical APIs and formulations
- Medical device testing
- Genotoxic impurity studies
- Raw material and excipient testing
Regulatory Standards
ICHUSPEPISO
Instrumentation
LC-MS/MS (Shimadzu LCMS-8045)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060NX)High Sensitivity LC-MS/MS (Shimadzu LCMS-8060RX)ICP-MS (Agilent 7800, SPS 4 Autosampler)GC-MS/MS-FID (Agilent 8890, 7000D GC/TQ)UV Visible Spectrophotometer (Shimadzu)FTIR Spectrophotometer (Shimadzu)
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.
ICH Q2ICH Q3DICH M7 (R1)USPEPBPJPIPFCCACSISO/IEC 17025ISO 10993-7US FDAEMACDSCO