MAA Registration
(Marketing Authorisation Application)

Your Gateway to the European Pharmaceutical Market

Aequum offers comprehensive support for Marketing Authorisation Application (MAA) registration, ensuring your pharmaceutical products comply with the EU's strict regulatory requirements. With our deep expertise in European guidelines and processes, we guide you through every stage of the MAA submission process—whether you're introducing a new drug or seeking approval for generics.
Our team manages the entire application, from compiling and submitting technical documentation to ensuring compliance with Good Manufacturing Practices (GMP) and other EU regulations. With our tailored regulatory strategies, we minimise delays and help you bring your products to market faster.

Our MAA Services Include:

  • Full dossier preparation and submission
  • Regulatory pathway assessment
  • Clinical trial data management and pharmacovigilance support
  • Coordination with EU regulatory bodies and agencies
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Aequum can be your trusted partner for securing swift and compliant market access.
Our regulatory expertise ensures that your products will meet all EU standards.

Get in Touch

Contact us

Address

Warehouse no. 25, Hard Rocks Industrial Park
Bumarrad Road, Naxxar, NXR 6345, Malta