Services From Onix
eSubmission: eCTD
- eCTD Submission Strategy
- eCTD Submission Timeline
- eCTD Compilation, QC Review, Technical Validation
and Submission Hosting - eCTD Lifecycle Project Management
- Importing and Cloning of
Existing eCTD Applications
eSubmission: Expertise
- Europe - Centralised, Decentralised,
Mutual Recognition, National Procedures, CTA and IMPD - USA - IND, NDA, aNDA, BLA and DMF
(incl. CRFs and Datasets) - Swissmedic
- Health Canada
- Australia
- ASEAN, GCC and Rest of World
eSubmission: Best Practices
- eCTD Consultancy and On-Site Training
- Industry Best Practices for
Regulatory Operations - Industry Best Practices for
Microsoft Word and PDF - Microsoft Word CTD Template Toolbar
using a One-Click Approach
(Module 1 Regional and Modules 2-5)
eSubmission: Gateways
- Europe - EMA Gateway and CESP
- USA - FDA Gateway
- Portugal - INFARMED
SMUH-ALTER Portal - Health Canada
eSubmission: PDF Publishing
- PDF - Ready for Submission
- Bookmarking
- Hyperlinking
- OCR (Optical Character Recognition)
- Embed Fonts
- Compliant with Regulatory Requirements
eSubmission: MS Word Publishing
- Word Formatting for PDF Conversion
- Table of Contents - Overall, Tables,
Figures and Appendices - Font Consistency Throughout Documents
- Internal Hyperlinking - Sections, Tables,
Figures, References and Appendices - Consistent Headers and Footers
and Page Orientation