EU MAH and QP Services Assistance
Masuu Global is a trusted provider of specialized services for the pharmaceutical industry, offering a comprehensive range of expert EU MAH & QP services. With a deep understanding of the pharmaceutical regulatory landscape in Europe, Masuu Global helps companies navigate the complex regulatory requirements, ensuring that their products are compliant with EU laws and are successfully introduced to the European market.EU Marketing Authorization Holder (MAH) Services
One of the core offerings at Masuu Global is our expert EU MAH & QP services, which are crucial for pharmaceutical companies seeking to market their products in the European Union. Under EU law, the Marketing Authorization Holder (MAH) is responsible for holding the marketing authorization for a medicinal product, ensuring that it is compliant with all EU regulatory requirements. As the MAH, Masuu Global can represent pharmaceutical companies in dealings with the European Medicines Agency (EMA) and national health authorities, ensuring that all required documentation, procedures, and post-market obligations are properly handled.
We provide end-to-end support for companies looking to enter the EU market. Our expert EU MAH & QP services include dossier filing, product registration, and coordination with regulatory agencies to ensure that every step of the process complies with European regulations. We also help with variations and renewals of marketing authorizations, ensuring that companies remain compliant with any changes in regulations over time.
Qualified Person (QP) Services
The Qualified Person (QP) is a critical role in the pharmaceutical industry, responsible for ensuring that medicinal products meet the required quality standards before they are released to the market. As part of our EU MAH services, Masuu Global provides QP services that are essential for pharmaceutical companies seeking to ensure the safety and efficacy of their products. Our QPs are highly experienced professionals who possess the qualifications and expertise required by EU law to certify that products are manufactured and tested in accordance with Good Manufacturing Practice (GMP) standards.
Masuu Global’s QPs can oversee the manufacturing and testing processes, ensuring that all regulatory requirements are met. This includes reviewing batch records, ensuring compliance with GMP guidelines, and certifying that the products are safe for release in the EU market. Our expert EU MAH & QP services enable our QPs to work closely with clients to provide timely and accurate advice on regulatory issues, helping to prevent delays in product launch and ensuring a smooth entry into the European market.
Masuu Global’s commitment to providing expert EU MAH & QP services ensures that pharmaceutical companies have the support they need to achieve regulatory success and maintain compliance with evolving EU standards.
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 wing 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.