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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).

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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.

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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.

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Experienced with Industry Leading Tools :

 

Lorenz DocuBridge, eCTD Express, eCTD Global, SUBMIT

Submission Formats

Application Types

  • eCTD – US, EU, Canada, GCC, Australia, Switzerland, South Africa, Jordan and Thailand

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  • NeeS – Australia, New Zealand, EU, Canada, GCC, Bosnia and Herzegovina

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  • pCTD – Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region

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  • 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

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

Document / Submission Level Publishing

Onsite / Offsite Publishing

Global Centralized Publishing Operations

eSubmission Troubleshoot Assistance

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