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 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 to 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 upon their requirements

• Freyr technology and Freyr resource support
• Client technology and Freyr resource support
• Client technology and client resource support