Developing a combination product or a medical device only?
Our regulatory services can help you determine the right pathway and the process to get there.
Aiming to collect early feedback from FDA?
We can help you assemble the documentation needed to gain regulatory clarity and facilitate effective pre-submission meetings.
STANDARDS & GUIDANCE REVIEW
Need help identifying the critical requirements?
We can help you identify the right consensus standards and agency documents. Then, we will pull the critical inputs and testing procedures needed to integrate into the development process.
REGULATORY SUBMISSION SUPPORT
Need support preparing your regulatory submission?
Whether you are preparing your IND, IDE, NDA, BLA, or 510(k), our team can help you prepare the materials needed to put your submission in t.
Looking for Regulatory Support?
Contact us through the form below. One of our regulatory team leaders will follow-up with you directly.