GLP Regulatory Bioanalysis

Two scientists in lab coats and safety glasses are intently reviewing a document together in a modern laboratory setting. Behind them, analytical equipment connected to computers suggests the ongoing analysis or research work. This image illustrates the collaborative and meticulous environment at Alderley Analytical, where expert teams conduct Good Laboratory Practice (GLP) regulatory analyses to ensure the accuracy and reliability of pharmaceutical and biomedical research findings.
This image captures a moment in a laboratory where a scientist's hand, covered with a blue glove, is adjusting or using an analytical balance. The balance, enclosed in a transparent draft shield to prevent air currents from affecting the measurements, displays a reading of

As a GLP certified laboratory, Alderley Analytical can meet the regulatory compliance requirements for your pre-clinical studies.

Our assays can meet the needs of the appropriate regulatory guidelines and our Quality Management System (QMS) allows us to fulfil the requirements of the governing regulatory bodies including MHRA and ICH.

The image presents a focused view of a scientist working within a laboratory environment, absorbed in reading or entering data on a smartphone or a small handheld device. The scientist is dressed in a lab coat, indicating a professional setting, and safety glasses, emphasizing the importance of safety precautions in the lab. The blurred effect, particularly around the edges and on the equipment in the foreground, suggests a focused depth of field, drawing attention to the scientist's concentration on the task at hand. This photograph captures the integration of modern technology in scientific research, illustrating how digital tools and connectivity are essential components of contemporary laboratory work. The use of a smartphone or handheld device in the lab setting could be for a variety of purposes, including accessing research data, controlling laboratory equipment remotely, or communicating with team members. The image subtly underscores the multitasking and technologically savvy nature of today's scientists, reflecting the evolving landscape of research where traditional laboratory practices meet cutting-edge technology.

GLP PRE-CLINICAL SAMPLE ANALYSIS

As a GLP certified laboratory, Alderley Analytical can meet the regulatory compliance requirements to quantify molecules in biological samples in support of your preclinical studies.

Assays used to support these studies will have been fully validated and the analysis will be conducted to meet the regulatory guidelines. Incurred Sample Analysis (ISR) will also be performed where required. Sample analysis data will be captured onto our validated LIMS system and the performance of the assays will be monitored in every batch of sample analysis performed. The data will be used to determine the Pharmacokinetics, Toxicokinetics or simple exposure values in support of your preclinical studies.

See how our GLP Regulatory Bioanalysis transitions into Clinical Bioanalysis or explore Immunogenicity assessments within GLP settings.

 

Contact us now to learn more

Contact Us