OUR INDUSTRY OFFERING
Are your documents CTD/eCTD ready?
Prepare future oriented documents conform to current and future standards and ready for reuse across multiple applications.
Are you conforming to the new ISO requirements for data storage?
Manage and maintain your regulatory documents in a document management system providing data security, access control and version control.
Are you spending too much time preparing your applications?
Compile and maintain your regulatory applications efficiently taking advantage of content re-use by cloning, merging and replicating content from one application to another. NEVER COMPILE ANYTHING TWICE. Automatically create paper volumes with table of contents (TOCs), tab sheets and consistent header and footers across all documents. Be future oriented and create dossiers today that can be used electronically tomorrow e.g. for eCTD and RPS.
Are your applications conform to technical specifications?
Validate your applications and ensure they pass technical validation at agencies with electronic validation criteria.
Are you on top of all your registrations?
Track all your regulatory activities and registrations in all of your markets in a secure environment. Manage your upcoming tasks and alerts, create management reports on the fly and never miss another deadline.
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.