EU MAH and QP Services Assistance
Masuu Global offers comprehensive support in various services essential for pharmaceutical companies operating within the EU market. Our EU Qualified Person (QP) services cater to Marketing Authorization Holders (MAHs), batch release sites (BRS), batch control site (BCS) and batch testing sites (BTS), ensuring compliance with stringent regulatory requirements.
Our experienced QPs are adept at triggering audits by EU agencies, conducting pre-assessment audits of pharma companies, and applying Corrective and Preventive Actions (CAPA) to address any non-compliance issues identified during internal audits.
In addition to audit support, Masuu Global provides assistance in the filing of dossiers and maintaining regulatory compliance throughout the product lifecycle. Our team of experts offers guidance in dossier management, ensuring that submissions meet all regulatory standards and requirements.
We understand the importance of adherence to current Good Manufacturing Practices (cGMP), and our support extends to helping clients navigate cGMP audits successfully.
Masuu Global is committed to partnering with pharmaceutical companies to navigate the complex regulatory landscape of the EU market, providing tailored solutions to ensure product quality, safety, and efficacy.