Marketing Applications

Bringing innovative healthcare solutions to market is a multifaceted journey, and our services offer a strategic roadmap tailored to various application types, resulting in projects firmly grounded in a clear pathway to market success. At Halloran, our regulatory team navigates programs through to marketing applications (NDAs, BLAs, PMAs, 510(k)s), providing guidance on critical late-stage development programs to ensure success. Whether acting as advisors, authors, or any role in between, we are committed to facilitating your journey to market authorization. This is the heart of our vision to enable life science innovation together and to improve human health around the world.

Our comprehensive suite of services encompasses a diverse range of application types, each meticulously designed to pave the way for market authorization:

• 510(k) Application: Guiding you through the 510(k) application process for medical devices, ensuring market access while meeting regulatory standards
• BLA (Biologics License Application): Assisting in preparing and submitting BLAs for biopharmaceutical products, ensuring compliance with regulatory requirements for market authorization
• MAA (Marketing Authorization Application): Helping prepare MAA submissions for European Medicines Agency (EMA) approval, facilitating market entry in the European Union
• NDA (New Drug Application): Providing NDA preparation and submission services, ensuring your new drug meets regulatory standards for market authorization
• PMA (Pre-Market Approval): Guiding you through the PMA process for medical devices, ensuring compliance with FDA requirements for market entry