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Non-GLP & Discovery Services

Enhance your drug development journey with our comprehensive Non-GLP & Discovery Services. At Biotrial Bioanalytical Services, we understand the vital role that good laboratory practices (GLP) play in ensuring the quality, safety, and efficacy of pharmaceutical compounds. Our experienced team of expert Bioanalytical Scientists is dedicated to providing innovative approaches that meet your requirements, from the early stages of preclinical research to clinical trials.

Non-GLP & Discovery Services: Our specialized services encompass a broad spectrum of activities critical to the success of your drug development program. We conduct GLP studies, ensuring that your compounds meet safety and toxicity requirements. We have extensive experience in both preclinical and clinical assays, offering you a complete package of quality data analysis

However, it’s important to note that in the realm of discovery bioanalysis, certain unique challenges arise. Often, the lab is “blind” to the analyte structure, making swift and intelligent decisions crucial for predicting drug uptake and elimination during compound identification and screening. To address these challenges, we employ a research-grade assay approach via LC-MS/MS for quick analysis in the early stages, allowing us to rank compounds efficiently.

Bioanalysis Expertise

Our state-of-the-art laboratory is equipped to tackle even the most complex assays. Under the guidance of Laurentiu Ciochina, a seasoned specialist with over 15 years of experience in bioanalytical research, we design tailored methods to meet your unique requirements. Even when confronted with uncommon drug administration and sampling techniques, we prioritize data quality.

In the context of discovery bioanalysis, we recognize that careful planning is essential to analyze samples without the need for formal validation. This is where our default protein precipitation LC-MS/MS method proves invaluable, offering an assay range of 1–5000 ng/mL and an array of calibration standards, ensuring accurate data even with small sample volumes.

Method Feasibility Studies

Determining the feasibility of your LC-MS/MS quantification approach is a crucial aspect of the drug development process. We understand that a good study design is a prerequisite for good data. Our feasibility assessments are conducted meticulously, providing you with a comprehensive feasibility report and conclusion to understand all facets of the project thoroughly.

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The Future of Drug Development :

In the dynamic world of pharmaceuticals, innovation is crucial to staying ahead. Biotrial’s Bioanalysis Services embraces innovative approaches without compromising data quality. Our services provide you with the data you need to make informed decisions and advance your drug development strategy.

Our services are meticulously designed to meet your specific requirements, whether you are embarking on the initial stages of drug development or progressing to clinical trials. We provide data analysis of unparalleled quality, ensuring the safety, efficacy, and regulatory compliance of your drug compounds. Choose Biotrial Bioanalysis Services as your partner for the future of drug development. Our dedication to quality, GLP compliance, and innovative bioanalytical methods make us the ideal choice for your discovery services.

In Vitro and In Vivo Testing :

At Biotrial Bioanalysis Services, we offer a wide array of assays to evaluate the pharmacological and toxicological effects of your substances. Our methods are rigorously validated, offering you reliable data to inform your pharmaceutical development program.

In the realm of discovery bioanalysis, understanding the balance between data quality, speed, and cost is crucial. We offer practical, standardized, fit-for-purpose non-GLP research-grade assays (RGA) to meet your specific needs across the drug continuum.

GLP Compliance and Regulatory Requirements:

Our commitment to regulatory compliance means that your studies conform to the necessary regulations and standards, whether it is preclinical or clinical research. This meticulous approach is at the core of our services.

Related Information

Method development & Method Transfer GLP Preclinical Sample Analysis Quantitative Bioanalysis using LC-MS MS Sample Management & Storage