Our Services – Pharmaceuticals & Veterinary Medicine
Bioanalysis
Bioanalysis for Life Science and Veterinary Medicine
CEMAS provides comprehensive, small molecule, bioanalysis solutions, tailored to R&D businesses, pharmaceutical and veterinary medicine companies to accelerate their drug development and biomedical research requirements. We have supported clients in both the human healthcare and veterinary medicine sectors for over 15 years during pre-clinical and clinical trials, in the quantification of drugs as well as their metabolic products. Our GxP, state-of-the-art facilities and expert team are dedicated to provide bioanalysis support for small molecule drugs. We aim to deliver precise, reliable, and timely analytical data, ensuring that your projects realise the highest standards of quality and efficiency and ensuring smooth progress into market authorisation.
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Pre-Clinical Bioanalysis
Where bioanalysis is crucial for understanding the pharmacokinetics (PK), pharmacodynamics (PD), and toxicology of your drug candidates. Our pre-clinical bioanalysis services include:
- Pharmacokinetic (PK) Analysis: Detailed studies of drug absorption, distribution, metabolism, and excretion to establish dosage and efficacy parameters.
- Bioanalytical Method Development and Validation: Tailored method development to meet specific study requirements, ensuring robustness and accuracy.
Clinical Bioanalysis
As your drug candidate progresses to clinical trials, our clinical bioanalysis services ensure comprehensive and reliable data to support regulatory submissions and efficacy evaluations. Our clinical services include:
- Bioanalytical Testing: Quantitative and qualitative analysis of your active and metabolites in biological matrices, including, for example, plasma, serum and urine.
- Pharmacokinetic Assessments: Providing insights into drug behaviour in human subjects.
- Clinical Trial Support: Complete bioanalytical solutions to support Phase I-IV trials, including sample analysis, data management and reporting.
- Regulatory Compliance: Adhering to GxP standards and regulatory requirements to ensure data integrity and credibility.
Our Bioanalysis Services
- Method Development and Validation – developing and validating robust, reliable analytical methods while adhering to regulatory guidelines to create customised methods tailored to your specific needs.
- Pharmacokinetic (PK) Studies – Providing end-to-end solutions to help understand the pharmacokinetics of your drug, including detailed insights into the absorption, distribution, metabolism, and excretion (ADME) of pharmaceuticals.
- Bioanalytical Sample Testing – offering high-throughput small molecule drug and metabolite sample testing services to support preclinical and clinical studies.
- Regulatory Assurance – adhering to Good Laboratory Practice and Good Clinical Practice guidelines.
- Additional Support – including expertise in receipt and analysis from clinical trials worldwide, storage of samples at -20°C and -80°C, with continuous computer monitoring of all storage locations. We can also undertake storage stability and degradation trials, freeze-thaw cycles and dried blood Spot (DBS) analysis.
Analytical Techniques and Infrastructure:
Our laboratories are equipped with the latest technologies, including:
- Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Freezers at -20°C and -80°C, with continuous computer monitoring for sample storage
- GLP and GCP compliance
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
