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eCTD Publishing and Regulatory Submission Services
We assist in compiling and submitting Electronic Common Technical Document (eCTD) applications with accuracy and compliance.
eCTD Publishing & Submission
Trusted Partner for eCTD Submissions
Artixio provides inclusive regulatory operation services to Pharmaceuticals (FP and API), Biopharmaceutical, and Healthcare, CMO and Clinical Research industry and we are dealing with regulated and semi regulated markets for submission in electronic format (eCTD, Nees and pCTD format). Artixio’s Regulatory operations’ qualified expert team has sound experience as Regulatory Operations professional which includes submission management/ planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch to regulatory authorities, archival and troubleshooting.
Artixio can support all kind of electronic submissions (eCTD and NeeS) like pre (original application, amendment to original application) and post approval (variations / supplement, annual report and PSUR / PADER) submission for US, Europe, Canada, Australia, South Africa and Gulf.
Electronic CTD Submission Formats
eCDT
- United States
- European Union
- Canada
- GCC
- Australia
- Switzerland
- South Africa
- Jordan
- Thailand
pCDT
- LATAM
- MENA
- APAC
- ASEAN
- CIS
NeeS
- Australia
- New Zealand
- GCC
- European Union
- Canada
- Bosnia
- Herzegovina
vNeeS
- European Union
eCTD Application Preparation and Submission Services
| Application Types | Dosage Forms |
|---|---|
| ANDA, NDA, BLA and IND | Oral Solid Dosage Form (Tablets and Capsules) |
| MAA via CP, NP, MRP and DCP | Parenterals (Powder for Injection, Solution and Suspension) |
| NDS, SNDS, ANDS, SANDS and CTA | Topicals (Cream, Ointments and Suppositories) |
| MAA for Generic and NCE via NP and GCC Procedure | Others (Ophthalmic, Otic and Inhaler) |
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Artixio For eCTD Application Publishing Help?
eSubmission Management & Strategy
Global Centraliz
Document / Submission Level Publishing
eSubmission Troubleshoot Assistance
Onsite / Offsite Publishing
Customer-centric, flexible services and solutions.
Industries We Serve in the European Union
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
Europe
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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