Artixio

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 TypesDosage Forms
ANDA, NDA, BLA and INDOral Solid Dosage Form (Tablets and Capsules)
MAA via CP, NP, MRP and DCPParenterals (Powder for Injection, Solution and Suspension)
NDS, SNDS, ANDS, SANDS and CTATopicals (Cream, Ointments and Suppositories)
MAA for Generic and NCE via NP and GCC ProcedureOthers (Ophthalmic, Otic and Inhaler)

Our Services

Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access

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

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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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