FDA Submissions and Pre-submissions, International Submissions, Review of Marketing Material, Letter to File, Add to File, Regulatory Strategy and Assessment.
- We have extensive experience with regulatory submissions.
- A history of sustaining clearance and approval
- Established rapport with regulators
- Good relationship with the FDA
- Technical and regulatory experience working together, without adding unneeded burden to your company
Our team is very good at using the presubmission process to identify the least-burdensome pathway to a clearance. Other groups can find it challenging once a submission has gone into the FDA.
We have experience being called in once a submission has gone into the FDA and the “additional information request” is sent back. Oftentimes the client’s current regulatory consultant doesn’t know how to address this development, but we have a long track record of success in these situations.
Our strategic approach to regulatory submissions is to get clearance and approval. We have the technical experience to understand what makes the point and what is just extra work. By being very strategic on what is submitted to the FDA, we can speed up the process.