With cGMP labs in the UK, Germany and US and a track record of success in regulatory audits, including the FDA, we have particular specialty in materials science and pharmaceutical analysis.
Our Solid Form Screening and Selection Centre of Excellence builds on our expertise in Materials Science analysis to offer discovery of high quality crystalline forms of small molecule development candidates. Our team has extensive experience in synthetic and medicinal chemistry and will work with you to tailor the screening protocols to maximise hit rate while minimising compound requirement.
Our Impurity and Contamination Centre of Excellence comprises two UK laboratories, which are regularly inspected by the UK MHRA for cGMP compliance.
• Detection of a full range of potential nitrosamine impurities
• Organic impurity characterisation and structural elucidation
• Inorganic trace analysis
• Extractable and leachable testing
• Contamination and foreign particulate analysis
We support the regulatory Chemistry, Manufacturing and Control (CMC) compliance of your drug substance and drug product through the complex challenges faced in drug development, solving issues at all stages of manufacture.