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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?

Are you looking for other product development consulting services independent of eCTD?

For further information on other consulting services please see: