Trusted testing expertise to safeguard quality, ensure compliance, and streamline pharmaceutical development.
Trusted testing expertise to safeguard quality, ensure compliance, and streamline pharmaceutical development
Microbiological and Analytical pharmaceutical testing is crucial to ensuring the safety, quality, and regulatory compliance of products. These tests detect harmful contaminants and verify the identity, purity, potency, and stability of drugs, safeguarding public health and ensuring consistent product quality. Conducting these tests in-house can be resource-intensive and complex.
By outsourcing to CLS, pharmaceutical companies can ensure thorough, reliable testing while focusing on their core competencies. Partnering with CLS for microbiological and analytical pharmaceutical testing not only guarantees compliance with stringent regulatory standards but also streamlines the entire drug development and manufacturing process.
Our Chemical and Analytical pharmaceutical testing services ensure that products meet the highest standards of safety, quality, and regulatory compliance. These tests help verify the biocompatibility of materials used in medical devices, ensuring that no harmful substances are released during use that could compromise patient safety or product performance.
With our advanced laboratory capabilities and adherence to FDA, HPRA, ISO, and other regulatory guidelines, we support manufacturers in maintaining product integrity and meeting stringent industry standards.
Water testing
Raw material testing
QC Release Testing
Finished product testing
Cleaning & detergent testing
Pharmacopoeias Testing (European, United States, BP, JP, ChP)
Method development
Method transfer
Analytical method verifications
Cleanroom validation
Retain sample testing and storage
We have a full suite of GMP microbiological pharmaceutical testing services, with experienced sampling analysts available for on-site sampling or the collection of client-taken samples.
We offer a wide range of customised validation projects, tailored to meet client needs. These may be pre-defined and scoped by the client, or developed in collaboration with CLS. Our team brings extensive expertise and knowledge, enabling us to design and deliver bespoke programmes that achieve precise and reliable outcomes.
Bioburden analysis
Endotoxin Testing (LAL)
Media fill
Microscopic ID’s in supporting product and clean-room monitoring
MALDI-TOF
PCR analysis
Bacterial yeast and mould
Absence of specific organisms
Microbial assessment and monitoring
Cleanroom validation
Water systems validation
Preparation of validation protocols & reports
ICH stability studies
Preservative Efficacy Testing (PE testing)
Method transfers from client sites to CLS
Test method validation
Process validation
Cleaning / detergent validation
Process simulation
Purified water systems
Material integrity validation
Pilot validation studies
Training/comparative validations
Method development to international guidelines
Trusted by leading names