Efficiently validate submissions by predefining requirements
Ensure that medicinal products meet regulatory requirements
Scale your processes with parallel work between multiple users
How much time do you spend assessing submissions?
Reviewing large volumes of data for compliance takes a lot of time without dedicated tools and processes.
- I’m pressured to reduce reviewing time and comply with procedural timelines
- We’re overwhelmed by the number of submissions to process
- I’m having difficulties identifying the changes in a submission within its lifecycle
- I’m frustrated by the lack of collaboration because documents are stored in multiple data silos
- We’re struggling with a complex infrastructure and are in need of a smarter automation
Validating and reviewing submissions within given timelines should be effortless
Easily navigate around the structure of a submission in different view modes.
Annotations can be exported easily to speed up the creation of your assessment report.
Validation at scale
Scalable for numerous internal and external users where IT resources may be limited.
Life cycle management
Quick access to submissions throughout the entire lifecycle of a medicinal product.
Your plan to effortless compliance
Schedule a call
We’ll discuss your goals and uncover your challenges.
Get a free consultation
Our team will analyze your current review processes.
Reduce your assessment timelines
Improve your assessment and validation processes.
Streamline your submission validation
Regulatory agencies are faced with increasing volumes of submission documents and data. The agency solution lets organizations review electronic submissions in a timely manner, enabling them to avoid backlogs and ensure that medicinal products meet regulatory requirements.
Request your personal EXTEDO Software Demo now!
Through the agency solution interface, you can access imported submissions and search, view, and annotate them. This powerful feature allows you to organize and filter submissions based on certain criteria, such as regulatory activities corresponding to the overall regulatory status of a drug product. As recognized by regulatory authorities around the globe, the agency solution is the requisite solution for effortless review and validation of regulatory submissions.
Some of our Customers
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 eCTD submissions. 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.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.