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Are your application specifications clearly defined?
Create clear guidance for Industry on the structure and format of their applications both in paper and electronic formats. Whether going eCTD or Electronic CTD or implementing electronic guidance for other formats e.g. Veterinary, Medical Devices, etc., be sure industry knows what you want through technical validation criteria. You will make your evaluations more consistent and enable more predictable review times through clearly developed specifications.
Are your applications conform to technical specifications?
Validate incoming applications and ensure they pass technical validation. Validation not only can check the application setup and document compliance, it can automate the initial screening process to ensure all the documents for a particular submission type have been provided.
Are you spending too much time preparing your applications?
Manage the application evaluation assignments and control access with a fully validated system. View applications over time with easy access to past data to improve evaluation quality. Annotate and comment directly in the applications without disrupting the delivered documents and export comments for use in expert reports. Ensure accountability through audit trails that will document all access and changes within the system.
Are you conforming to the new ISO requirements for data storage?
Manage and maintain your evaluation reports and applicant correspondence in a document management system providing data security, access control and version control.
Are you on top of all your evaluation activities?
Track all your registrations, regulatory activities and evaluation status for all your product categories e.g. Chemical, Biological, Prescription, OTC, Complementary, Veterinary, Medical Devices, DMFs, Clinical Trials, etc. Have a clear overview of activities via interactive dashboards and extract reports effortlessly.
Are you ready for your electronic regulatory systems?
Ensure you do not overlook any aspects of moving from paper based methods to electronic processes. Let our experience help you along the way.