Supporting CDx, personalized medicine, and biomarker clinical trials in the U.S. and EU
We help align the regulatory paths of Pharma and IVD manufacturers
As a Pharma company or diagnostic partner, you navigate a complex and evolving regulatory landscape for developing and commercializing personalized medicine and Companion Diagnostics (CDx). Challenges include integrating diagnostic and therapeutic development, designing and conducting combined studies, and moving from Clinical Trial Assays conducted in centralized labs for early phase clinical trials to CDx kits for global commercialization and managing dual regulatory pathways for therapeutic products and IVDs.
At Qserve, we bring together a team of seasoned consultants with hands-on experience in the medical device industry and regulatory bodies. Whether you're a startup building your first QMS or an established company preparing for certification, we work alongside your internal teams to embed quality into your daily operations.
Satisfied Clients
Our CDx services cover the entire lifecycle of CDx and personalized medicine:
Consultancy
We provide regulatory consultancy support across the entire IVD product development lifecycle, from defining the diagnostic strategy, selecting diagnostic partners, and implementing clinical study processes to post-market activities.
Audits & Assessments
We conduct in-depth audits and gap assessments and support supplier qualification to ensure compliance with global IVD regulations, including IVDR, ISO 13485, CAP/CLIA, ISO 15189, and the IVDR in-house exemption.
QA Support
We support pharma companies, IVD manufacturers, and laboratories in setting up regulatory-compliant QMS processes for CDx, Clinical Trials Assays, and regulatory-compliant clinical study conduct.
Regulatory Intelligence
We facilitate expert-driven workshops and strategic dialogues to align stakeholders on regulatory, clinical, and market pathways for CDx and Clinical Trial Assays.
Interim Support
We provide flexible resourcing solutions, such as interim experts, project-based support, or full functional outsourcing, to extend your team’s capabilities.
Training
We provide flexible resourcing solutions, such as interim experts, project-based support, or full functional outsourcing, to extend your team’s capabilities.
Global Market Access
We offer support for pre-market applications in the U.S. (FDA) and IVDR conformity assessment in the EU, ranging from authoring submission documents to supporting the selection of a Notified Body, to helping during regulatory submissions and meetings with regulatory authorities.
Clinical Research
We assist with defining the CDx clinical strategy, analytical and clinical study design, study submission (US IDE and IVDR CPS authorization), study conduct, and monitoring to generate robust clinical data and ensure regulatory compliance of CDx and Clinical Trial Assays.
Developing companion diagnostic products and using Clinical Trial Assays in combined studies requires aligning pharma and diagnostic strategy and timelines, as well as collaboration between pharma and diagnostic partners. Without clear regulatory guidance or internal expertise, teams risk delays with study submission and conduct, failed partnerships, or pre-market approval of a CDx — all of which can impact therapeutic product approval timelines and commercialization.
We have practical experience working with many pharma companies and diagnostic test providers. We support both parties to ensure your CDx program is connected — scientifically, clinically, and strategically. From analytical and clinical study design and regulatory submissions to preparing for global commercialization, our team helps to streamline operations and minimize delays.
We have practical experience working with many pharma companies and diagnostic test providers. We support both parties to ensure your CDx program is connected — scientifically, clinically, and strategically. From analytical and clinical study design and regulatory submissions to preparing for global commercialization, our team helps to streamline operations and minimize delays.