BLA/NDASave as PDF
A Biologic License Application (BLA) or a New Drug Application (NDA) are required by the US Food and Drug Administration (FDA) allowing a company to introduce a product into interstate commerce in the USA.
Applications in eCTD format can be submitted via FDA's secure Electronic Submission Gateway (ESG). As a consultancy, ERA is fully versed in using the submission gateway and holds the required credentials to complete submissions through the ESG on behalf of clients.
ERA can support you in understanding and fulfilling the requirements for filing submissions to FDA as well as conducting the complete preparation and submission of a BLA or NDA in eCTD format.
How can ERA's eCTD group help?
- Compilation and submission of a BLA or NDA as eCTD via FDA's Electronic Submission Gateway (ESG)
- Conversion and submission of an existing BLA/NDA previously submitted in paper format
- Support in various kinds of questions regarding the preparation and submission of BLAs/NDAs in eCTD format
- Interaction with FDA, pre- and post-submission
- For information on IND please click here.
Are you looking for other product development consulting services independent of eCTD?
- Preparation/Authoring of BLA/NDA
- Support for your (pre-) BLA procedure
- Advice on your filing strategy
- US Agent services
- And other consulting services regarding biotechnological and biological products as specified on our website
For further information on other consulting services please see: www.eraconsulting.com