Drug Registration with EMA Member States

Comprehensive Drug Registration Services
At Statim Ltd, we understand the complexities involved in drug registration across EMA member states. Our team provides end-to-end support, from regulatory strategy to dossier preparation and submission, ensuring your product is registered successfully in multiple markets.

Our Drug Registration Services:

  • Centralized Procedure Management: Handling the entire process of centralized drug registration with the EMA.
  • National and Mutual Recognition Procedures: Expertise in navigating the varied requirements of different member states.
  • Regulatory Dossier Preparation: Ensuring all documentation, including the Protocol, IB, IMPD, and ICF, is meticulously prepared to meet member state standards.
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