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Butterworth Laboratories Ltd – Experts in Pharmaceutical Analysis Products

Butterworth Laboratories Ltd – Experts in Pharmaceutical Analysis

Method Development Validation Services Method Development ensures a procedure is designed for determining an analyte in a specific sample. This includes choosing the most appropriate sample preparation method and analytical technique. Subsequent method validation ensures that the method is specific, linear over the desired range, accurate, precise and robust. This ensures that it is fit for purpose and can be routinely reproduced in a laboratory setting by any suitably trained analyst.
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Pharmaceutical QC Testing Quality Control (QC) analysis of pharmaceutical raw materials and finished products to cGMP ensures compliance with international standards and ultimately helps to ensure patient safety.
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GLP Laboratory Services GLP studies are carried out at the pre-clinical stage of development and are aimed at providing data on the safety of materials used in a medicine. These studies are strictly controlled and compliance is regulated by the appropriate regulatory body, in the UK this is the MHRA.
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Stability Storage and Testing Services Stability studies are performed to assess material or product performance over time by means of storage under controlled conditions of temperature, humidity and light. Analysis at a variety of time intervals helps to ensure the safety and efficacy over the designated shelf life.
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Clinical Trial Sample Analysis This is the quality control analysis of products to be administered during a clinical trial and has the aim of ensuring safety prior to use. It can also be the analysis of biological samples taken from the patient during a trial. The latter requires additional GCP controls within a laboratory quality system to ensure patient safety.
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