Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
The Q-Submission program is the best opportunity to engage with the FDA and get valuable feedback on your product’s classification, regulatory pathway, and test plan to support a future submission. If done properly, the submission process can yield more timely and cost efficient results. At AlvaMed, we can provide the conduit between our clients and the FDA.
Organize a plan to address areas where critical feedback is needed to ensure the efficiency of a meeting with the FDA.
Using the pre-submission guidance information, create a template including specific questions for the FDA, ensuring they are addressed with supporting documentation. This information will be used to garner feedback from the FDA pertaining to the submission pathway in preparation for a formal meeting.
Upon review of the FDA’s written feedback, assess the need for any additional information and points of further clarification. Schedule a formal meeting to discuss remaining topics.
Provide the FDA with detailed meeting minutes including points agreed upon and any supplemental information where necessary. Upon further feedback from the FDA, adjust submission accordingly.
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
It’s 75 degrees and sunny and I’m on my front porch thinking back on all the great work that has been done over the last six months. I feel quite fortunate to have found such a great team to work with in AlvaMed. We seriously could not have done this without you. This has been one of the most challenging projects I have ever been involved with. Looking back, I feel AlvaMed was the perfect choice.
Pfizer
AlvaMed completed the registration for the company and coached the company president in the FDA registration process.
CASE STUDY
There are six different types of Q-Submissions, each addressing specific needs such as premarket clearance pathways, clinical trial design, and labeling. Determining the right type is crucial for efficient feedback and avoiding delays.
Reference the FDA’s guidance document for additional information.
Content requirements vary based on the Q-submission type, but typically include a clear description of the device, intended use, proposed testing or data, proposed classification and specific questions for FDA feedback.
Once received by FDA, the review is generally completed within 60 days. Written feedback is provided approximately 5 days in advance of a meeting if requested.
Eric has experience guiding clients through Q-Submission meetings across a multitude of therapeutic areas and devices including implants, SaMD and others.
Schedule a meeting with Eric to learn how AlvaMed can help with a successful Q-Submission.
