PeploBio Information

A UK based (ISO 15189 accredited and ICO registered) Contract Research Organisation (CRO) committed to providing cutting-edge solutions to the biopharmaceutical and healthcare industry. PeploBio provides access to the latest Molecular and ELISA based technologies, enabling broad biomarker detection. As a science led organisation, we partner with you to combat the most challenging testing needs, by delivering bespoke services, including assay development and assay validation. The highly experienced clinical and research-focused team of PeploBio consisting of PhD and HCPC registered scientists, enables us to be at the forefront of discovery, translational and clinical research. We are committed to enhancing precision medicine in the immune monitoring, genomic, proteomic and metabolomic space. Specialisms: - Bespoke Assay Development and Assay Validation services - Regulatory Affairs - Medical device & reagent manufacturer approval support e.g. CE-IVDR, CTDA and UKCA - Worldwide sample logistics and sample procurement, including rare disease types. - High sample testing capacity (molecular and serology-based testing) - State-of-the-art Quality Management System (QMS) recognised by leading regulatory bodies - ISO 15189 accredited and ICO registered organisation as both quality and data protection are of utmost importance - Use of Laboratory Information Management System (LIMS) to ensure operations and data management workflows are streamlined, efficient and secure. Achievements: - 91.6% Acceptance rate by Leading Regulatory Bodies for over 50 Clinical Evaluations we have conducted. - Average of 2.9 months in completing (CER’s) medical device & reagent validations. - 4.74/5 ★ Client Satisfaction Rating