Artixio

Global Life Sciences Publishing & Submission Services

Global Electronic Publishing Services for Pharmaceutical Products using Leading Technology Platforms

Streamlining Regulatory Publishing with Expertise

Artixio provides integrated, regulatory publishing and submission services to pharmaceuticals (finishes products, active pharmaceutical ingredients), Biotechnology products and companies for submission in regulated and semi regulated markets in electronic formats (eCTD, Nees and pCTD format).​ Artixio’s Regulatory publishing’s qualified expert team has solid experience for both new submissions (IND, NDA, MAA) and lifecycle submissions across the publishing lifecycle including submission management/ planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch to regulatory authorities, archival and troubleshooting.​.

← Publishing Lifecycle →

New Submissions

Lifecycle Submissions

Submission Planning & Management

Document Level Publishing (DLP)

Submission Level Publishing (SLP)

Affiliate SuppoSubmission Dispatch / Electronic Submission (XML format)

Archival

Troubleshooting

Submission Formats Supported: eCTD, NeeS, pCTD, vNeeS

Application Types:

Dosage Forms:

Global Coverage:

Technology Based, Regulatory Intelligence Driven Global Publishing and Submission

Solid publishing team with multi-country experience
Centralized project management and global submission oversight​
Global delivery model for 24x7 publishing support
Fast Turn Around, Urgent Delivery Model
Experience with world leading publishing platforms
Flexible Business Model: Project Based, Long Term Multi Year Engagement
Cost Effective Pricing: Unit based, Time and Material Based​
First Time Right
Accurate publishing output
Global Handshake supporting multiple time-zones
Quality driven processes and procedures
Data Security

FAQS About Publishing and Submission Services

What are the key components of Publishing and Submission Services?

The key components of publishing for pharmaceutical application dossier submission include understanding the regulatory requirements for publishing in country of interest, identifying the right format and key components of the document, applicable format for submission (eCTD, pCTD, NeeS etc), submission gateways (ESG etc), suitable publishing software, submission planning and trackers, quality check at each level of document and submission level publishing, submission to health authority and archiving.

Our centralized publishing and submission team has experience in publishing dossier in multiple formats, products and dosages forms across multiple countries worldwide. We have established processes and procedures to ensure high quality, right first time publishing submissions based on our experience and quality driven systems and KPIs.

The key challenges faced by pharmaceutical and biotech companies during publishing include, understanding of country specific publishing requirements and guidelines, lack of established processes, lack of experienced in house team for publishing, availability of cost effective software for publishing, shorter deadlines and time sensitive multiple submission requirements, experience in multi-country experience, among other challenges.

Artixio’s centralized regulatory intelligence team, process and technology platform continuously track new regulations, guidelines, notifications, updates from global health authorities as well as track insights using our regional teams and their network with regional trade and industry associations. New information is processed, structured and stored in our central repository that provides actionable insights supporting publishing and submission activities.

Still Have Questions ?

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Specialized Regulatory Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Services Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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