End-to-End Companion Diagnostics (CDx) and Precision Medicine Expertise

Our services in device development encompass strategic guidance, project management, and comprehensive operational support throughout all phases of CDx development:

• Notified Body engagement: 
  Support with selection, contracting, and ongoing liaison.
  
  
• Submission and review support:
  Guidance through the submission and review process with the Notified Body.
  
  
• Quality Management System implementation:
  Assistance in setting up or optimizing a compliant QMS.
  
  
• Clinical evidence strategy:
  Define an optimal, compliant, and pragmatic approach to demonstrate scientific validity, analytical performance, and clinical performance.
  
  
• Clinical performance study design & implementation:
  Design and full-service execution of Annex XIV-compliant performance studies in the EU.
  
  
• Legal representation:
  Acting as your legal representative for study applications under IVDR Article 58(4).
  
  
• Medical writing & submission package:
  Preparation or review of study documentation, with tailored submission strategies for each EU member state.
  
  
• Risk management:
  Support in developing a comprehensive risk management file in line with ISO 14971.
  
  
• Representative services:
  Acting as your EU Authorized Representative, UK Responsible Person (UKRP), and Swiss Authorised Representative
  
  
• IVDR & CDx Training:
  On-site or remote training on regulatory and operational aspects of CDx studies across the EU, UK, and Switzerland. 

At QbD Group, we understand that the successful development of a medicinal product relying on a companion diagnostic (CDx) requires a coordinated and well-structured development plan. The interdependence between the drug and its diagnostic affects key regulatory, clinical, and quality considerations throughout the entire lifecycle, from proof of concept to marketing authorisation.

Building on the CDx components of your program, QbD Group can also support the development of the medicinal product itself, ensuring that all interlinked requirements are seamlessly reflected in your overall regulatory and development strategy.

Services provided by QbD Group in this context include, but are not limited to:

• Regulatory Strategy and Pathway Definition:
  Identifying the most appropriate regulatory route for the medicinal product in view of its dependence on a companion diagnostic; alignment with EMA expectations for co-development.
  
  
• Target Product Profile (TPP) and Biomarker Integration: 
  Defining the therapeutic indication, patient population, and diagnostic use conditions within the TPP and clinical development plan. 
  
  
• Clinical Development Planning and Study Design:
  Ensuring the inclusion of diagnostic-related endpoints, stratification criteria, and patient selection strategy within clinical trials supporting the medicinal product.
  
  
• Clinical Trial Applications (CTAs):
  Preparation of the required documentation (e.g., IMPD, IB, protocol, etc) and submission to the relevant health authorities and ethics committees, including full support during the validation and assessment phases of the application.
  
  
• MAA Dossier Preparation:
  Drafting and integrating relevant sections of the CTD for the medicinal product, reflecting the link with the diagnostic and demonstrating how CDx performance supports the clinical benefit–risk profile.
  
  
• Interactions with Diagnostic Partners and Health Authorities:
  Assisting with coordination between the drug sponsor and the diagnostic developer; preparation for EMA scientific advice or parallel consultations to ensure consistent messaging and alignment of development timelines.
  
  
• Quality Management System implementation:
  Development and audit-readiness for compliant QMS integration.
  
  
• Post-Approval Support:
  Managing updates to the medicinal product dossier related to diagnostic changes, new biomarkers, or expanded indications.