Publishing and Submission - Overview
MAA publishing and submission is a critical step in the entire generic drug approval process as it includes all documents and information submitted to the Regulatory agency for review. Generic MAA submissions must be made in accordance with the standard Regulatory procedures and formats as recommended by the EMA. Due to the enormous amount of information present in the MAA, EMA has made it mandatory for generic applicants to submit all documents and other information in eCTD format. The applicants must make sure the eCTD submitted is technically valid and submitted within the deadline. There can be a risk of delay in the initiation of the procedure in case if there is any technically invalid sequence is observed.
Freyr, with qualified Regulatory publishing and submission experts and a robust eCTD publishing and submission software, helps clients overcome Regulatory submission challenges to ensure error-free submissions and timely approval of generic medicines. We provide our clients with various models of service depending on their requirements
- Freyr technology and Freyr resource support
- Client technology and Freyr resource support
- Client technology and client resource support
Publishing and Submission - Expertise
- Support for end-to-end generic medicine applications Regulatory submission and publishing including submission level and document level publishing activities
- Generic MAA submissions in paper, NeeS and eCTD formats
- Conducting multi-level QC checks and reviews of documents before submitting them to the clients/HA
- Continuous project monitoring
- eCTD submission strategy right from initial submissions to lifecycle management in alignment with ANDA submission requirements of the HA
- Creation of a detailed tracker to track all the changes made throughout the publishing lifecycle
- Freyr SUBMIT PRO - Regulatory publishing and submission tool
