Decentralized (DCP) and Mutual Recognition (MRP) Procedure Management:
Decentralized Procedure (DCP) Management:
We provide strategic counsel to optimize your approach to DCP submissions, considering factors such as the target countries and product specifications.
Our experts ensure that your product’s regulatory strategy aligns with the published national requirements of the concerned member states.
Coordination and Submission:
ERA manages the coordination of DCP submissions across multiple countries, ensuring that all documentation is accurate and complete.
We facilitate communication and collaboration between the involved regulatory authorities to expedite the approval process.
Our team ensures that your DCP submissions comply with the varying regulatory requirements of each member state.
ERA proactively addresses any potential regulatory queries or concerns to minimize delays.
Mutual Recognition Procedure (MRP) Management:
Optimized MRP Strategy:
We develop a tailored MRP strategy that leverages existing marketing authorizations to expand into new member states.
Our experts guide you through the MRP process, maximizing efficiency and reducing duplication of efforts.
ERA facilitates discussions and negotiations to resolve any regulatory challenges.
By choosing ERA for your DCP and MRP procedure management, you gain a partner dedicated to simplifying the regulatory pathway for market access in multiple European Union member states. Our commitment to strategic planning, precise coordination, and regulatory compliance ensures that your product achieves approvals efficiently and effectively.