Centralised Procedure Management

At ERA we can help with the centralised procedure process including but not limited to:

Strategic Planning:

Customized Regulatory Strategy:

We develop a tailored regulatory strategy to guide your product through the centralised procedure efficiently.

Our experts consider factors such as therapeutic area, competition, and regulatory pathways to optimize your chances of success.

Application:

Comprehensive Dossier Compilation:

Our team meticulously compiles and prepares the regulatory dossier, ensuring that all required documents and data are accurate and complete.

We work closely with you to gather the necessary scientific evidence and documentation.

Quality Control and Validation:

ERA implements stringent quality control and validation processes to ensure that your application meets the highest standards.

We minimize the risk of regulatory queries or delays by addressing potential issues proactively.

Agency Interactions:

Communication with Regulatory Authorities:

We serve as your liaison with the European Medicines Agency (EMA) and other regulatory bodies throughout the application process.

ERA ensures that all communications are clear, timely, and in compliance with regulatory requirements.

Response Management:

If regulatory queries or concerns arise, we provide timely and effective responses to address these issues. Our experts are well-versed in managing interactions with regulatory authorities to resolve any challenges.

Project Oversight:

Project Planning and Oversight:

ERA manages all aspects of the centralised procedure project, from initial planning to final approval. We keep you informed of project milestones, timelines, and any potential deviations.

By choosing ERA for your centralised procedure management, you gain a partner dedicated to guiding your product through the complex regulatory process in the European Union. Our commitment to strategic planning, dossier excellence, effective agency interactions, and project oversight increases the likelihood that your product achieves regulatory approval and market access