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Regulatory Publishing and Submission Services For Life Sciences
Expert regulatory publishing and submission services for pharmaceutical and other lifesciences products. We offer global electronic publishing using leading technology platforms. Comprehensive Regulatory Publishing & Submissions Management for life sciences companies.
Services We Offer
Streamlining Global Publishing and Submissions
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
- IND / CTA
- NDA / MAA
- ANDA
Lifecycle Submissions
- Variations
- Renewals
- SPL
Submission Planning & Management
Document Level Publishing (DLP)
Submission Level Publishing (SLP)
Affiliate SuppoSubmission Dispatch / Electronic Submission (XML format)
Archival
Troubleshooting
Regulatory Submission Formats Supported:
eCTD, NeeS, pCTD, vNeeS
Application Types:
- 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)
- Parenteral (Powder for Injection, Solution and Suspension)
- Topicals (Cream, Ointments and Suppositories)
- Others (Ophthalmic, Optic and Inhaler)
Global Coverage:
- USA, Canada, Europe, Australia, South Africa, Gulf, China and others
Technology Based, Regulatory Intelligence Driven Global Publishing and Submission
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.
How do you support Publishing and Submission in multiple countries?
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.
What are the key challenges faced by Pharmaceutical companies during Publishing?
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.
How do you stay updated with changing regulations in international countries related to Publishing and Submissions?
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 ?
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
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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