Dynakin has a decade of experience in providing contract laboratory services to the industry’s leading biotech and pharmaceutical firms. In a GLP certified environment we propose a full range of services for non-clinical and clinical drug development programs:
- Development of new assays applied to early discovery, preclinical regulatory toxicokinetics and pharmacokinetics and clinical pharmacokinetics and bioavailability studies
- Transfer / adaptation and cross-validation of existing methods
- Validation of assays according to international guidelines and regulations (EMA and FDA)
- High throughput analysis of samples collected during preclinical and clinical studies
- Analytical and regulatory support for clinical trials, Pharmacokinetic (PK) studies, and bioequivalence studies
Dynakin provides method development, assay validation and specimen analysis for small molecules in several matrices, including blood, plasma, urine and tissues using liquid chromatography and mass spectrometry (LC-MS/MS). Method development and validation are our specialties. Methods are developed and validated in accordance with either client-specific protocols or internal SOPs and all methods are validated to meet EMA, FDA and/or ICH guidelines. High sample throughput is made possible with UPLC-MS/MS instruments, and fasted and semiautomatic sample preparation procedures.
The bioanalytical team is integrated by a laboratory manager, a Head of the Laboratoryr, as well as study directors, analysts and maintenance technicians. All of them are highly trained in all facets of analytical work including equipment maintenance, sample handling, sample extraction, run set-up and data processing. According to the GLP each project has an assigned study director in charge, who leads a team of analysts and technicians dedicated to your project.
The majority of our staff holds a PhD, a Master’s Degree or a Bachelor’s degree in chemistry, pharmacy, or Biology, and proven experience of 5 to 20 years in bioanalysis. Significant effort is placed on training laboratory staff. This includes not only the scientific/technical aspects but also in providing an advanced understanding of the regulatory framework involved in bioanalytical support of drug development process. This is crucial in our expert reporting that includes full pharmacokinetic intrepretation of results in discussion with the sponsor. This is an important advantage of Dynakin’s biolab services.
We believe strong lines of communication between our business and yours are essential for the successful completion of projects, and we will customize our approach to meet your unique demands. Laboratory management, and all study directors are directly involved in all aspects of study conduct so that they can give immediate and accurate status report to sponsors. From your initial inquiry to the final report, Dynakin will be with you each step of the way, providing a high quality service to our sponsors.