Q-Submissions
The FDA’s Q-Submission (Pre-Sub) process allows early dialogue to de-risk your submission and receive feedback on testing plans, classification, or data strategy.
We support clients by:
- Crafting precise questions and briefing documents
- Leading agenda-setting and FDA communication
- Mitigating regulatory risk early in the submission process
- Using our strong FDA relationships to guide productive outcomes
We help you use the Q-Sub process to your advantage—whether you’re preparing a 510(k), De Novo or PMA.
Trusted by top-tier teams worldwide
Featured case studies
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…