EU Marketing Authorisation Application (MAA)

Background of EU Marketing Authorisation Application (MAA)

The marketing authorization application (MAA) is a critical regulatory document required for medicinal product approval in the EU. The MAA is a comprehensive dossier that includes information on the quality, safety, and efficacy of a medicinal product, as well as information on its manufacturing and control processes. Based on the MAA, regulatory agencies can assess the ability of prospective marketing authorization holders (MAHs) to ensure and monitor a sustainable benefit/risk ratio. The MAA must comply with EU regulations and guidelines issued by the European Medicines Agency (EMA). A medicinal product can only be placed on the European Economic Area (EEA) market after marketing authorization from the relevant authorities.

About Us

Our team of experts provides comprehensive services for MAA submission to help clients navigate the complex regulatory landscape in the European Union.

The MAA process in the EU is a complex and highly regulated process that requires a team of regulatory affairs experts. As a regulatory affairs consulting firm, our services related to the MAA, including MAA strategy development, dossier preparation, and regulatory authority interactions, are designed to help clients navigate this process and achieve timely approval of their medicinal products. Our competitive advantage lies in our deep expertise, customized approach, and commitment to excellence. We are committed to continuous improvement and are always looking for ways to enhance our services and stay at the forefront of the regulatory affairs consulting industry.

European Filing Procedures

We help our clients with all the logistical and regulatory aspects of the MAA submission process. We file MAA in the following ways:

• National procedure—For obtaining market access in specific EU countries
• Centralized procedure—For submitting a single MAA
• Mutual recognition procedure—For manufacturers who have already obtained market access in one of the EU member states
• Decentralized procedure—For drugs that have not yet been approved by the EU

Our EU MAA Production Services

We provide our clients with efficient and one-stop solutions for submitting high-quality MAAs for entire Europe in support of filing and approval processes. Our team of experts guides the complete process and documentation required for MAA filing, review, and approval. Our services include, but are not limited to:

• Local representative in the EU
• MAA writing and submission services
• Dossier due diligence and dossier audit
• Conversion of CTD/NeeS documents to eCTD
• Dossier module writing for MAA: EU administrative and prescribing information, high-level summaries, quality documentation, non-clinical documentation, and clinical documentation
• Assistance in response to requests for additional information
• Submission of MAA to EU countries as per the schedule via various procedures and managing the complete procedure until approval and further life cycle management assistance
• Communication with regulatory health agencies
• Assistance in assessment report interpretation and response to various steps of different submission procedures
• Assistance in submitting MAA to European health authorities
• eCTD publishing services
• eCTD compilation, QC review, and technical validation
• eCTD publishing for MAA dossier
• eCTD lifecycle management
• MAA submission procedure management services
• MAA life-cycle management
• MAA revision preparation and eCTD publishing
• Query response to support amendment filing for safe approval
• Revising and updating the MAA

If you need help or have a question, please feel free to contact us for more details.