Compiling an FDA submission is not easy. If the submission has errors, you may be putting the future of your product at risk. However, BioNovaLead Group can make sure you get it right the first time and shorten your time-to-market by eliminating costly mistakes.
FDA Submission Services
- Regulatory strategy consulting
- Medical device meetings
- Study risk determination
- Breakthrough device designation
- Companion Diagnostics (CDx) clinical study design
- IDE
- Pre-submissions
- PMA
- De novo
- 510(k)
- 513(g)
- IND
- Digial Health