Business Process and Regulatory Consulting Services

Ensure industry compliance and improve the quality and consistency of your submissions 

At EXTEDO, we understand the challenges associated with ensuring industry compliance and maintaining the level of quality and consistency of your submissions. Our services cover the entire regulatory landscape.

NeeS to eCTD Services

EXTEDO's end-to-end publishing services are designed to help your organization meet current and future electronic submission requirements. From planning and development of dossier standards, to creation and delivery of eCTD compliant submissions for the regulatory authorities, our team will ensure that your applications are handled swiftly and produced faultlessly.

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Regulatory Submission Publishing Services

To support your regulatory department, EXTEDO and its partners provide a broad range of regulatory submission publishing and training services.

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Regulatory Intelligence Services

EXTEDO’s regulatory intelligence services cover the entire regulatory landscape - from compliance & business processes evaluation to NeeS/eCTD gap analysis and system migration. Our team of experts will help you meet regulatory obligations and identify areas where operations and processes can be improved, thus ensuring maximum efficiency & operational excellence.

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Pharmacovigilance Services

EXTEDO’s Pharmacovigilance Business Process consulting services are tailored specifically to your needs. Based on many years of experience working with drug safety rules and regulations, EXTEDO´s team will help you identify gaps in your pharmacovigilance processes and support your organization in developing and implementing the appropriate strategies PSMF to resolve them.

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eSubmission, eCTD and RPS Process Services

Based on many years of experience within the Life Science industry, we will help you properly plan your electronic submissions; simplifying and structuring your processes and communications. EXTEDO’s team will help you identify the gaps in your business and regulatory processes and support to develop the appropriate strategies to eliminate them.

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Regulatory Agency Services

EXTEDO's time-tested approach is designed to help you improve the efficiency and processes within you regulatory agency. EXTEDO’s team will help you to identify opportunities for improvement within your agency's processes and define the appropriate actions required to eliminate them.

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