eCTD Publishing & 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.
Experienced with Industry Leading Tools
Submission Formats
eCDT
United States
European Union
Canada
GCC
Australia
Switzerland
South Africa
Jordan
Thailand
NeeS
Australia
New Zealand
GCC
European Union
Canada
Bosnia
Herzegovina
pCDT
LATAM
MENA
APAC
ASEAN
CIS
vNeeS
European Union
Application Types
ANDA, NDA, BLA and IND
MAA via CP, NP, MRP and DCP
NDS, SNDS, ANDS, SANDS and CTA
MAA for Generic and NCE via NP and GCC Procedure
Dosage Forms
Oral Solid Dosage Form (Tablets and Capsules)
Parenterals (Powder for Injection, Solution and Suspension)
Topicals (Cream, Ointments and Suppositories)
Others (Ophthalmic, Otic and Inhaler)
Services & Models
eSubmission Management & Strategy
Global Centralized Publishing Operations
Document / Submission Level Publishing
eSubmission Troubleshoot Assistance
Onsite / Offsite Publishing
Blogs
