10 Small Submissions
No more than 10 Documents per submission
US based Global Biopharmaceutical company with major focus on Hematology, Cardiovascular, Immunology, Fibrotic Diseases and Neuroscience based products.
The goal was to implement a system that can create EAEU eCTD compliant submissions.
To compile, validate, and publish EAEU Regulatory submissions efficiently based on decisions and rules set by different Health Agencies
Demonstration
Oct -19
Kick-Off
10500 Product Registrations
Jun - 20
User Acceptance Testing
10+ Countries
Jul - 20
Go-Live
185+ Users Globally
Jul - 20
On-Premise and Cloud based platform offering 24X7 accessibility and availability
Web-based solution offering dynamic feature - rich modules which are highly configurable
Flexibility in integrating with Freyr’s Software Suite as well as with any third-party Regulatory tools using APIs