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
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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