This robust, scalable, global collaborative solution supports planning and management of product-related submissions throughout the submission lifecycle, post-submission, and post-approval management. It enables cross-functional collaboration within the company as well as with external partners, and supports global, harmonized, and local process definitions. SubmissionExpert provides predefined data models, document types, and processes, as well as worldwide submission structures, procedures, and publishing capabilities – all out of the box. It is unique in the market: it has been evolving continuously since 2003, and has been recognized as market-leading by numerous companies.
Thanks to its extreme configurability, this solution can be quickly adapted to changed regulatory or business requirements. Eliminating the need for expensive upgrades, it assures low total cost of ownership and can be easily rolled out to new sites or organizational units.
Region-specific submission structures for dossier planning and assembly
Collaborative document management and reporting
Collaborative submission planning, tracking, management, and reporting
Electronic (ECTD, NEES) and paper publishing according to regional specifications
Business Intelligence analytics and reporting
Create, compile, and manage regulatory submissions
It increases productivity and operational efficiency, and hence helps overcome regulatory affairs challenges and meet regulatory affairs goals of the pharma, generics, biotech, and medical device industries. One environment. One authoritative source of truth.
CREATE YOUR SUBMISSIONS FASTER
Communicate effectively and accurately with health authorities and partners. Achieve timely and sustainable compliance.
PROTECT THE QUALITY OF REGULATORY SUBMISSIONS
Ensure that your company obtains and maintains the appropriate marketing approvals, licenses and registrations to market its product on a global basis with a given budget and resources.
INCORPORATE AND ENFORCE DATA STANDARDS. INCREASE THE VALUE OF INFORMATION
Replace multiple siloed applications and establish a single authoritative source of regulatory information. Save time and effort with single data entry. Reduce complexity and costs.
LIFE SCIENCES SOLUTIONS
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