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Marketing Applications

How we help with Marketing Applications

Bringing your innovations to improve human health is a complex journey. Our services provide a strategic roadmap for a range of application types, ensuring projects are anchored in a clear pathway to market success. Halloran’s regulatory team can see programs through to marketing applications (NDAs, BLAs, PMAs, 510(k)s) and beyond. We advise our clients on critical late-stage development programs to ensure success. We can act as advisors, authors, and everything in between.

Our services encompass a diverse range of application types, each designed to provide you with a clear path to market authorization:​

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

​With our expertise spanning these diverse application types, we provide the strategic guidance, preparation, submission, and follow-up support needed to ensure a smooth market entry for your life science innovations.