Qarad can support the development of your companion diagnostic from early phases in clinical trials up to bringing it to the EU market.
Our consultants are ready to support you with strategic regulatory advice, mapping out each step you need to take or provide ad-hoc support when needed.
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Our trainers provide on-site or remote trainings on general or specific items of the IVDR, and on regulatory requirements for use of a CDx under development in a clinical trial.
We can act as legal representative, which is mandatory to appoint if you as a sponsor for the CDx under development are established outside of the EU.
If you’re not based (or have subsidiaries) in the EU, the UK and Switzerland, we offer authorized representation services to get your product registered in these countries.
Our experienced team of medical and technical writers can support you in either writing or reviewing the documentation that must be submitted as per Annex XIV to national competent authorities and ethics committees to get approval (Clinical Performance Study Plan, Investigator Brochure, Performance Evaluation Plan, Informed Consent Form…) for using a CDx under development in a clinical trial. We have the intelligence what each member state specifically expects as documentation and also bring our in-house experience to what type of questions you can expect during the review and how long such application takes from submission to approval.
We are also ready to support in writing or reviewing the technical documentation which must be submitted to the notified body to get marketing approval. We also help to select and contract the notified body.
In preparation of clinical trials, we can act as a liaison between the IVD manufacturer and the pharma sponsor, translating different regulatory needs and ensuring timelines on both ends will be met.
Our team of seasoned auditors can make sure your quality management system is ready to meet IVDR (and notified body) requirements.
Our QbD Group’s Business & Communications division is comprised of expert strategists, scientists, communicators, and creatives. The QbD Business & Communications team can be a sounding board, or even an extension of the client’s team to help ensure that an innovative idea, ground-breaking product, or stellar service receives the strategy, funding, and visibility it deserves to optimize the chances of commercial success. QbD Business & Communications are not just consultants but support all aspects of the client’s marketing and communications including implementation.
