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

pCDT

NeeS

vNeeS

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)