Regulatory full features

Submission for Human drugs

Support for eCTD, CTD (paper) and NeeS submission formats
Sequence management and variation control with change tracking
Validation tool for submissions to the FDA, Health Canada, EMA, GCC and SwissMedic health authorities
Submission assembly templates compliant with the ICH eCTD specifications for m2 to m5
Integrated Regulatory document management aligned with DIA EDM reference model
Hyperlink and Study Tagging File (STF) management

Submission for Animal health

Electronic submission in vNeeS format
Sequence management and variation control with change tracking
Pharmaceutical, Immunological and MRL products
Validation checker for vNeeS
Integrated Regulatory document management
Hyperlink management and PDF generation

Submission for Medical devices

eCopy submission management for 510(k) and PMAs
Original submission and hold notification review
Management of general and specific controls for Class I, II and III
Validation checker in compliance with the FDA eCopy program Guidance
Integrated Regulatory document management
Hyperlink management and automatic PDF naming

Regulatory Information Management

Planning and tracking of regulatory activities
Submission management
Health authority correspondence and commitment tracking
Product registration management, XEVMPD, IDMP, SPL
Automatic notifications for renewal and PSUR submissions


Unique ID reference code generator
Two-step electronic signature verification
Full audit trail
ICH, GxP and FDA 21 CFR part 11 Compliant
Validation toolkit for IQ, OQ and PQ verification


Automatic periodic reports
Data export in Excel and/or XML file
Real time dashboards
Statistics and other dynamic quality indicators
Business Intelligence and data mart capabilities


Solr search engine (as used by Google)
Full text search on document content and metadata
Advanced search using multiple selection criteria
Quick search tool
Configurable and sortable search results display and views


iPad app for document management
View and sign your document from anywhere
Offline synchronization
Available as a cloud-based deployment
Full web based browser independent solution
Local language capability is ideal for multi-site deployment

Information system integration

Cloud-based or on-premises deployment options
Fully configurable, turn-key solution requires zero programming
No IT skill required for administrators
Highly scalable architecture
REST API to connect to other enterprise systems (ERP, MDM (Master Data Management), PLM)
Email and scanner connectivity