Improve and optimize your electronic submission management and processes
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTDmanager implementation. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach for your specific eCTDmanager usage.
Simplify and streamline your eCTD submission data
Ensure compliance with eCTD submission requirements
Optimized eCTDmanager configuration and processes
Streamlined business processes and improved compliance
Based on many years of experience within the life science industry, our time-tested approach is designed to help you properly plan your submissions; simplifying and structuring your processes and communications to ensure that they align with your eCTDmanager implementation. 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.
At EXTEDO we are dedicated to helping you meet and exceed your business objectives and assist organizations with:
- Developing submission lifecycle processes to ensure effective management of regulatory information
- Establishing document lifecycle processes that guarantee eCTD-ready documentation
- Regulatory best practice workshops to provide you with an understanding of global requirements
- Submission readiness assessments to evaluate your organization’s readiness to submit regulatory applications
- Conversion of submissions from NeeS to eCTD
- Non-eCTD region submission template creation