Good Laboratory Practice (GLP) Studies Services by MDS Denmark

MDS Denmark offers specialized services in conducting and managing Good Laboratory Practice (GLP) studies, essential for the pre-clinical stage of medical device and pharmaceutical development. Our GLP study services are designed to ensure that all laboratory activities are carried out in full compliance with internationally recognized Good Laboratory Practices, ensuring the reliability, reproducibility, and regulatory acceptability of study data.

We support both in vitro and in vivo testing, with a particular focus on animal trials when required for biocompatibility, toxicology, or other pre-clinical assessments. These studies are conducted under strict GLP conditions to meet the expectations of regulators such as the EMA and FDA. .

KEY ASPECTS OF OUR GLP STUDY SERVICES

Compliance with GLP Standards

We ensure that all aspects of our GLP studies adhere to international Good Laboratory Practices, including proper study planning, execution, monitoring, recording, archiving, and reporting.

Study Design and Protocol Development

Our experts assist in designing studies and developing detailed protocols that meet specific research objectives while ensuring full GLP compliance. This includes identifying appropriate study models, controls, and methods – particularly when animal trials are required.

Quality Control and Assurance

We implement rigorous quality control and assurance procedures throughout each study, including oversight of documentation, data handling, and traceability – ensuring full integrity of results.

Data Management and Reporting

Our services include complete data management – from raw data collection to final reporting. We ensure that all reports are compliant with GLP and suitable for regulatory submission in both EU and international contexts.

Facility and Equipment Management

We maintain high standards for laboratory infrastructure, including equipment calibration and environmental control, to meet GLP conditions for pre-clinical testing.

Staff Training and Expertise

Our team comprises highly trained professionals with extensive knowledge of Good Laboratory Practices. Continuous training ensures that all study personnel are up to date with the latest GLP requirements and best practices.

WHY CHOOSE MDS DENMARK FOR GLP STUDIES?

Expertise in Pre-Clinical Research

We have extensive experience supporting GLP-compliant animal trials and laboratory studies for medical devices and combination products.

Regulatory Alignment

Our studies are structured to meet EU and international submission requirements, whether for CE marking or FDA approvals—ensuring your pre-clinical data stands up to global regulatory scrutiny.

Customizable Study Services

We tailor each GLP study to match your research objectives, timelines, and regulatory targets, whether for initial biocompatibility screening or full pre-market data generation.

ENSURING RELIABLE AND COMPLIANT PRE-CLINICAL STUDIES

MDS Denmark’s Good Laboratory Practice services are vital for generating reliable, high-quality data in support of regulatory applications. Whether you require in vitro studies or animal trials, our GLP-compliant approach ensures that your data is accepted by regulatory authorities and supports safe and effective product development.