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Precision Medicine and Performance Evaluation Solutions for Medical Devices (IVD) and Companion Diagnostics (CDx)
About PeploBio
Explore Our Competitive Edge
PeploBio is a clinical contract research organization (CRO) at the forefront of regulatory affairs and clinical testing. With a cutting-edge molecular laboratory capable of processing 5,000 samples/day, our ISO 15189-accredited facility emerged as a top private lab in the UK during the COVID-19 pandemic. We have since evolved as an organization to offer regulatory consulting and immune monitoring services, furthering our mission to excel science in the field of medical devices and technologies.
Our comprehensive service package includes product development, clinical trials, and report drafting, thus supporting IVD/medical device manufacturers in market entry. Additionally, we provide a variety of immune monitoring, proteomic, genomic, and diagnostic services. Powering innovation and advancement, PeploBio is a trusted partner for those seeking transformative healthcare solutions.
Our UKAS Accreditation communicates to clinicians that our quality standards, aligned with ISO 15189, meet global laboratory standards, yielding robust data you can count on.
We are ICO registered, meaning we prioritize data protection and meet the requirements for GDPR compliance.
As a BIVDA member, we have access to cutting-edge regulatory insights, helping to inform robust regulatory strategies and fostering connections across the industry.
Life Sciences Review recognized our lab's excellence and regulatory adherence as the Top Clinical Laboratory Services Company in the UK in 2022.
Secure global market success through PeploBio's regulatory expertise.
Clinical Performance Evaluation
As part of our testing services, we offer performance evaluations including analytical, clinical and usability studies, to align with your specific market objectives.
PeploBio advises on the In Vitro Diagnostic Regulation (IVDR), an essential requirement for any company wishing to market in vitro diagnostic medical devices within the European Union (EU). The IVDR outlines standards for establishing a medical device's quality, safety, and integrity for diagnostics in vitro. IVDR is also accepted in markets like Asia and Africa, broadening your device's potential impact.
Although the United States is a major market, it is one of the most challenging regions to secure approval. We provide consultant services for interacting with the Food and Drug Administration (FDA) and securing FDA approval. PeploBio can provide expertise in developing robust regulatory strategies to achieve success in the US market.
The UKCA marking is critical for those seeking to manufacture certain medical devices in Great Britain. Our services assess your product to ensure conformity with UKCA requirements, allowing you to display the UKCA marking to communicate compliance.
To market COVID-19 test devices in the UK, you must obtain Coronavirus Test Device Approval (CTDA) for your product. PeploBio is an expert in preparing CTDA submissions, maximizing your company's chance of regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) to market in the UK.
We help you to establish your medical device's Quality Management System (QMS), supporting your accreditation journey. By creating a suite of policies, procedures, and processes within your QMS, you can ensure the safety and efficacy of your product.
At PeploBio, we are a leader in clinical trial development and biospecimen sourcing services
Immunoassay
We integrate immunoassay development into our unique suite of services. Immunoassays are critical in clinical diagnostics, allowing you to characterise the quality of your product and fuel clinical decision-making. We offer an array of platforms and capabilities, including BD FACSLyric, Molecular Devices SpectraMax ID5, ELISA, peptide and antibody screening, cellular phenotyping, receptor occupancy, and TBNK.
As part of our immune-monitoring effort, including our ELISA and flow cytometry services, PeploBio provides assays to pharmaceutical companies to support exploratory, phase 1, and phase 2 clinical trials. Additionally, we offer assay validation testing using our regulatory expertise to facilitate the development of companion diagnostics.
Running a clinical trial and bringing your product to market is no easy feat. At PeploBio, we believe in an integrated approach to drug and device development, which is why we offer clinical trial project management services to oversee your program from start to finish.
We provide extensive experience within the cutting-edge realm of genomics. Likewise, PeploBio has several offerings to help you successfully utilize genomic data, including qPCR sequencing, Sanger sequencing, CRISPR, gene silencing, targeted gene expression analysis, and gene sequencing.
High-quality biospecimen procurement is an essential component to progressing your device's program. We have extensive access to biospecimens through a diverse network of collection sites, providing a wide array of biospecimens for your company's individual needs. In addition, PeploBio delivers a host of biospecimen sourcing services in line with quality and bioethical standards.
Services
Diagnostics
Your ultimate partner for comprehensive diagnostic solutions and unmatched expertise
Partner Hub
PeploBio provides diagnostic testing solutions in the fields of oncology, infectious disease, serology, and more. By joining our partnership, you can access various services providing support in digital marketing, kits, account management, and more. Our partner program offers tiered subscription options, ranging from basic to comprehensive packages. By providing a spectrum of services, PeploBio offers customized solutions for everyone suited to your individual needs and goals.
Our state-of-the-art diagnostic testing laboratory offers dozens of testing services, securing PeploBio as your one-stop shop for all things diagnostics. In addition to our array of tests, we are ISO 15189 accredited with decades of experience in the field of molecular biology, providing the expertise you need for diagnostic testing success.
