Companion Diagnostics (CDx)

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

• Notified body engagement: Assisting with the selection, contracting, and engagement with notified bodies.

• Submission and review support: Guiding you through the submission and review process of your CDx with the Notified Body.

• Quality Management System implementation: Helping with the implementation of a compliant Quality Management System (QMS).

• Clinical performance study design & implementation: Assisting with the design and implementation of your clinical performance study applications in the EU, as per Annex XIV.

• Legal representation: Acting as your legal representative for clinical performance study applications under IVDR Article 58(4). Read more

• Medical writing and submission package: Reviewing or writing your submission package, along with offering detailed insights on the complex submission strategy in EU member states.

• Market access strategy: Assisting in developing a market access strategy that encompasses regulatory and reimbursement requirements across various geographies.

• Health economic assessments and payer engagement: Providing guidance on health economic assessments, pricing, reimbursement negotiations, and engaging with payers.

• Authorized representation: Acting as your authorized representative for EU, UK, CH under Article 2(25) IVDR.

• IVDR and CDx Training: Providing on-site or remote training on general or specific aspects of the IVDR, and the regulatory requirements for the use of a CDx under development in clinical trials in the EU, UK, and CH.

The QbD Group’s expertise extends to the medicinal product aspect of Companion Diagnostic development, where we provide services including:

• Notified body engagement: Assisting with the selection, contracting, and engagement with Notified Bodies.

• Submission and review support: Guiding you through the submission and review process of your CDx with the Notified Body.

• Marketing authorization application: Assisting with the submission and review of marketing authorization applications for medicinal products.

• Quality Management System implementation: Helping with the implementation of a compliant Quality Management System (QMS).

• Clinical trial applications: Assisting with the submission and maintenance of clinical trial applications under the Clinical Trial Regulation (EU) 536/2014 (CTR) in the EU, and the Medicines for Human Use (Clinical Trials) Regulation in the UK.

• Medical writing: Reviewing, writing, and publishing all eCTD modules required for obtaining marketing authorization.

• Market access strategy: Assisting in developing a market access strategy that encompasses regulatory and reimbursement requirements across various geographies.

• Health economic assessments and payer engagement: Providing guidance on health economic assessments, pricing, reimbursement negotiations, and engaging with payers.

• Regulatory requirements training: Offering both on-site and remote training on the regulatory requirements for performing clinical trials on medicinal products in the EU and UK.