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.
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