Tailored bioanalytical services for preclinical to clinical studies, primarily for biologics/large molecules, biosimilars, peptides, and gene therapy products
We offer bioanalytical services for preclinical and clinical studies including PK/PD analysis, immunogenicity, and biomarker testing. With the speed and flexibility of a small company and the experience and quality of a large one, we strive to have a deep understanding of your project’s specific needs from an early stage. This way we ensure rapid turnaround times while providing a cost-effective service.
We specialize in the analysis of large molecules such as biologics, biosimilars, peptides, and oligonucleotides. Our analytical platforms include ELISA, Meso Scale Discovery (MSD), SPR (Biacore™), and MBeads. Additionally, we offer LC-MS/MS analysis through our audited partner.
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Our service process
Together with our clients, we evaluate the project needs and feasibility.
Exchange of detailed project information is ensured to facilitate a comprehensive understanding of the project.
At Mercodia, we recognize the critical importance of involving the right competences from the early stages to ensure the success of the project.
The initiation of the project is marked by the signing of the quote. Subsequently, a dedicated team comprising project managers, scientists, study analysts, production managers, and other relevant personnel is promptly assigned to the project.
During this phase, the execution/analytical plan is designed, agreed upon, and formally signed.
Additionally, relevant activities such as risk assessment and the formulation of risk mitigation plans, data transfer agreements, and/or detailed specifications are elaborated.
Throughout the execution phase, adherence to the execution/analytical plan is maintained. Milestones and activities aimed at mitigating risks are undertaken, with simultaneous updates on project status, deliverable transfers, and adherence to predetermined Stop&Go decisions.
The project finalization phase involves the delivery and acceptance of results, along with the handover of the project report if previously agreed upon. Subsequently, a comprehensive project review is conducted, providing feedback on the services rendered.
This phase also includes discussions about potential follow-up projects and future collaborations.
Expertise that matters
Our team of scientists have expertise in handling complex sample types such as blood, plasma, serum, urine, and tissues sourced from different animal species as well as humans. We possess extensive knowledge in the field of cardiometabolic therapy and adhere to regulatory guidelines such as ICH GCP, EMA, and FDA. We are GLP-approved and have vast experience in conducting studies that comply with regulatory requirements for bioanalysis in drug development.
We offer our expertise in product development, quality assurance, quality control, and project management throughout the planning and execution stages to ensure the success of your project. Our team understands that each project is unique and requires a customized approach. We are committed to working together with you to deliver cost-effective and timely bioanalytical strategies that yield accurate and reliable data. Let’s collaborate and discuss how we can help you reach your milestones.
Annika Carlsson Director Bioanalytical Services