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 :
Lorenz DocuBridge, eCTD Express, eCTD Global, SUBMIT
eCTD – US, EU, Canada, GCC, Australia, Switzerland, South Africa, Jordan and Thailand
NeeS – Australia, New Zealand, EU, Canada, GCC, Bosnia and Herzegovina
pCTD – Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region
vNeeS – European region
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
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
Document / Submission Level Publishing
Onsite / Offsite Publishing
Global Centralized Publishing Operations
eSubmission Troubleshoot Assistance