ResLabQ&C Ltd
Clinical Research Laboratory
Quality and Compliance
Regulatory Approvals
The submission of an expertly prepared application for regulatory approval can save several months. ResLabQ&C can work with you to achieve this so that you are able to drive your research forward faster.
Ethical Approval
From the set up of an individual specific research study, right up to a large and complex research biobank, ResLabQ&C can support the entire process of obtaining research ethical approval.
We can help by crafting scientifically sound and regulatory-compliant study protocols, and by developing Participant Information Sheets, Consent Forms, recruitment posters, and other applicable documents. We can also oversee the submission and review of your ethics application, right through to approval.
HTA licensing
If the nature of your work means that you require an HTA licence in the research or application sector, ResLabQ&C can advise on the requirements for licensing, the implications of setting up and maintaining compliance with the licence conditions, and assist with completion and submission of the application form to the HTA.
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We can also assist with the preparation of the Preparation Process Dossier (PPD) required as part of the initial licence application in the application sector, or if you intend to adopt a new process or tissue/cell type, or to make significant changes to an existing preparation process. PPDs must be able to assure the HTA that all processes used to prepare tissues and/or cells for patient treatment have been validated and that the product is suitable.
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