MAASave as PDF
A Marketing Authorisation Application (MAA) needs to be filed to local or European authorities in order to gain market approval for a newly developed medicinal product.
Filing an MAA in eCTD format has become mandatory in many European countries, including applications using the Centralised Procedure (CP) to EMA. "eCTD only" submissions will become compulsory in all European countries in the near future.
Different electronic portals are available for the submission of applications via CP in electronic format to EMA (eSubmission Gateway/eSubmission Web Client) or for submission via mutual recognition or decentralised procedure (MRP/DCP) to national authorities using the Common European Submission Platform (CESP). As a consultancy, ERA is fully versed in using both submission portals and holds the required credentials to complete submissions through the ESG on behalf of clients.
ERA can support you in understanding and fulfilling the various agencies' requirements for filing submissions to EMA and/or local authorities as well as conducting the complete preparation and electronic submission (via CD or electronic portal) of an MAA in eCTD format.
How can ERA's eCTD group help?
- Compilation and submission of an MAA as eCTD via CD/DVD or electronic portal
- Conversion and submission of existing applications previously submitted in paper format (baseline submission)
- Support for various kinds of questions regarding the preparation and submission of applications in eCTD format
- Interaction with regulatory agencies, pre- and post-submission
Are you looking for other product development consulting services independent of eCTD?
- Preparation/Authoring of MAA
- Support with your list of questions
- Preparation of variations
- Advice on your filing strategy
- Conversion and submission of existing applications previously submitted in NTA format
- 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