Pharma Cloud eCTD Submissions Management logo

We are offering Pharma Cloud eCTD, Electronic Submissions Management Solution and services. Our Pharma Cloud eCTD Submission management application automates the electronic submissions of drug applications to regulatory agencies. Pharma Cloud eCTD Submission Manager facilitates the planning, creation, review, approval, publishing archival and management of regulatory filings – product applications and related sequences, You can efficiently manage your documents throughout the submission life cycle from application planning phase through post-marketing.

 

The application types supported

Individual New Drug(IND) Application
New Drug Application(NDA)
Abbrevated New Drug Application(ANDA)
Biologics Application(BLA)
Drug Master File(DMF)

 

Key Features

CFR 21 Part 11 compliant
Product registrations
Support in CDER/CBER submission types
Automatic business validations
Speed up submission life cycle process
Reusability of prior submissions
Automatically build and manage study tagging files(STFs)
Electrionic submissions of amendments, supplements and annual reports
Role based security access privileges and control
Security management
Workflow management
Document granularity
PDF hyperlinking
Audit Management

 

Features included

Submission Roadmap
Planning Submission dates
Create application
Personalized dashboards
Work in progress / Final preview
Automated validations
Workflow based approvals
Compilation
Publishing
Archiving
Tracking all submissions

 

Benefits

Shorten submission review lifecycle
High efficiency in communication between the sponsor agency and regulatory authorities
Drastically reduce costs
Maximize reusability of data across submissions
eCTD is a harmonized structure that facilitates reusable submission
Option to reuse certain CTD modules for other regulatory agencies like EMEA, Health Canada, etc.

Please contact us for furthetr information at 512-692-9842 / 408-416-3812 or by email to ectd@intelligentbiotech.com