National Procedure Management

Strategic Planning:

Customized Regulatory Strategy:

• We work closely with you to develop a tailored regulatory strategy for each target country in the EU and UK, considering local requirements, timelines, and market dynamics.
• ERA ensures that your product’s regulatory pathway aligns with your business goals.

Market Access Insights:

• We keep you informed about market access trends, reimbursement policies, and pricing strategies specific to each country.
• Our experts help you make informed decisions to maximize market penetration.

Application Preparation:

Documentation and Submission:

• ERA assists in preparing and submitting the required documentation for national regulatory approvals.
• We ensure that your submissions are accurate, complete, and in compliance with local regulations.

Local Representation:

• We can act as your local representative, interacting with regulatory authorities and facilitating communication on your behalf.
• ERA establishes and maintains a strong regulatory presence in each target country.
• ERA is also the only Irish member in a pan European network of regulatory affairs consultants called EuDRAcon, giving us greater insight and knowledge of the local requirements

Regulatory Compliance:

Regulatory Requirements:

• Our team stays updated with the latest regulatory changes and requirements in each country.
• ERA ensures that your submissions and ongoing regulatory activities remain in compliance.

Variations and Renewals:

• We manage variations and renewals of national authorisations, ensuring that your products maintain regulatory compliance and market access.
• ERA addresses any regulatory queries or changes promptly.

Timely Approvals:

Timelines and Project Management:

• ERA provides project management support to ensure that regulatory submissions and approvals are on track and meet deadlines.
• We keep you informed of progress and potential deviations.

By partnering with ERA for national procedure management, you gain a dedicated ally in navigating the complex regulatory landscape of individual countries. Our commitment to strategic planning, precise documentation, regulatory compliance, and local representation ensures that your products achieve timely approvals and market access in each target country.