In this blog article, we will outline the critical components of the EMA submission process for medical devices, digital health and AI.

The FDA’s guidelines for biosimilarity and interchangeability are crucial for ensuring that these products meet rigorous standards of safety

This article outlines the essential requirements for a successful BLA submission.

The Electronic Common Technical Document (eCTD) format is now the standard for regulatory submissions to the FDA.

A well-prepared IND application ensures that clinical trials can begin smoothly and that investigational therapies can move closer to market

The FDA’s 510(k) pathway is a critical regulatory route for bringing new medical devices to market in the United States.

Our team at Boston Biotech Advisors can significantly boost your odds of a successful IDE submission.