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eCTD Publishing & Submissions

eCTD Publishing & Submission
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.
Experienced with Industry Leading Tools
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
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

IND (Investigational New Drug)


NDA (New Drug Application)


Regulatory Operations

Services & Models

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
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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