MA Renewals are regulatory submissions required to extend the validity of a product’s marketing authorization after its initial approval period (commonly 5 years in the EU and many other regions). After the renewal is granted, the authorization typically becomes indefinite, provided the product continues to meet regulatory requirements.

Reassessments are formal regulatory reviews of an already authorized product to ensure its ongoing benefit-risk balance remains positive. These may be routine (e.g., periodic) or triggered by safety signals, new scientific data, or changes in guidelines.

Techsol’s offers end-to-end support for Marketing Authorization (MA) Renewals and Reassessments, ensuring full compliance with global regulatory requirements. Our approach to renewals includes the systematic collection and analysis of updated safety, efficacy, and quality data, including critical documentation such as Periodic Safety Update Reports (PSURs) and benefit-risk evaluations. We prepare and maintain the required dossier components particularly Module 1 and updated sections of Modules 2 to 5 and manage timely submissions to Health Authorities to avoid any disruption in market authorization.

For reassessments, Techsol provides strategic oversight by identifying regulatory or safety-driven triggers, reviewing cumulative clinical and post-marketing data, and conducting robust benefit-risk assessments. Where applicable, we manage interactions with Health Authorities to support label updates, usage restrictions, or re-evaluation requests. Our regulatory professionals ensure that your product remains aligned with the latest scientific evidence and regulatory expectations, enabling long-term market continuity and patient safety.