Publishing and Submission

 At Artixio we understand how great it is when you have a single destination for all your eCTD publishing and submission needs. Our Publishing and Submission suite offers end to end support right from preparation of publishing documents to their submission to health authorities using a team of expert publishers, metrics driven processes and KPI based quality assurance system; Artixio is your one stop solution for all your eCTD publishing and submission requirements.

INTEGRATED SOLUTION

Our Intelligence driven innovative platform supports eCTD submissions using real time insights from the health authority updates worldwide. We ensure error free regulatory submissions with global health authorities in eCTD, NeeS, Paper, ACTD formats via electronic gateway using our in-house home-grown publishing software. Our services and software is complemented with publishing staffing and resources augmentation support as a leading staffing services provider for your resource fulfilment needs whether at your premises or act as your back end team from our location in USA, India and Switzerland.

SERVICES

Artixio offers end to end publishing support, our team has in depth knowledge and expertise in managing regulatory fillings for global health authorities with core understanding of latest publishing trends and accepted submission formats. We assist our clients in maintenance and management of their global multi country document preparation, compilation and submissions to health authorities.

Artixio has expertise in catering to various formats of publishing and submissions accepted across the globe. We cater to eCTD (electronic Common Technical Document), NeeS (Non-eCTD electronic submissions) and Paper submission to United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), ANVISA, Brazil, Health Canada, Cofepris Mexico, PMDA Japan, NMPA China, TGA Australia, NAFDAC Nigeria etc.

Artixio offers an in-house eCTD publishing and submission management software, that adheres to the regional and ICH specifications.

  • New Drug Application (NDA), Investigational New Drug (IND), Abbreviated New Drug Application (ANDA), 510k submissions, Medical Devices Submissions, Nutraceutical and Cosmetics Submissions, Cosmetic Product Safety Report (CPSR), Biological License Application (BLA), Drug Master Files (DMF Submissions), Structured Product Labeling (SPL) Submissions, Supplemental new drug application (sNDA Submissions), ), Over the Counter (OTC), Annual report Submissions, Variations, Amendments, Labeling Supplement Submissions, Periodic Benefit-Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADERS), Periodic Safety Update Report (PSURs), Ad Promo Submissions, Legacy Conversions, Clinical Study Report (CSRs), eCTD Submissions for lifecycle management (LCM), Baseline Submissions, Clinical Trial Applications (CTA), Generic Drug Fillings

  • Marketing Authorisation Application (MAA) for Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP), New MA filings, Renewal of MA, Variation Type 1 and Type 2, Response to Questions (RTQs), Clinical Trial Application (CTA), AtoQs, Renewals, Originals, Variations, ASMF eCTD Submissions, Medical Device Submissions, Cosmetics Submission, Nutraceutical and Food submission, OTC/FMCG submissions and notifications

  • New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Supplement to a New Drug Submission – Confirmatory (SNDS-C), Abbreviated New Drug Submission (ANDS), Supplement to Abbreviated New Drug Submission (SANDS)


Our Expertise:

  • Preparation, Management and maintenance of documents as per health authority requirements
  • Conversions of legacy documents in different formats such as Paper to Non-eCTD electronic submissions (NeeS) to eCTD conversions
  • Gap analysis and suggestions to clients on processes
  • Keeping up to date with market trends and latest regulatory norms advised by health authorities
  • Intelligence driven regulatory publishing and submission
  • Regular tracking for data in different versions and changes maintaining the publishing lifecycle of submissions
  • Project management and multiple levels of quality check
  • Seamless and time driven submission using our in-house publishing and submission software
  • Well qualified team of publishers with experience in handling Report level publishing, document-level publishing, Submission level Publishing
  • 24X7 global support model

Artixio understands the regulatory landscape and understands the requirement of publishers for global submissions like MAA, ANDA, IND, NDA, SPL, 510k, Amendments in eCTD, NeeS, Paper format for health authorities such as USFDA, EMEA, Health Canada, PMDA, TGA, etc.
Our expertise include:
  • Regulatory Publishing and submission Coordinators
  • Regulatory Proof readers
  • Regulatory Publishing and Submission Managers
  • Senior Publishers
  • Project Managers


Our Subject Matter Experts have decades on experience in multiple types of submission for Biopharmaceutical, Medical Devices, Cosmetics and Nutraceutical line of products with adequate knowledge and experience with Legacy conversions, Clinical Study Reports, Dossier preparation and submissions as per health authority guidelines.
We have our in-house publishing and submission software catering to global regulatory requirements. Our experience in catering to client requirements have led us to develop a tool with unique feature which acts as both SaaS (Software as a Service) model and Software as a tool model. Our eCTD software is a robust, fully compliant, web-based software to create, manage, compile, publish, review, validate, archive the dossier in eCTD format for all eCTD accepting countries i.e. USA, Europe, Canada, GCC, Jordan, Australia, Switzerland, South Africa, and Thailand, etc. with maximum Regulatory (Regional and ICH) specifications, validation, and compliance catering to Biopharmaceutical and life sciences industry,
It intended for both cloud (access anytime, anywhere) or in‐house deployment (using company static IP address).
Unique features
  • Auto leaf title, file name and PDF properties corrections
  • Effective dashboard to track scheduled and overall submissions
  • Robust Country-wise application access with flag indicator
  • Effective dossier and submission summary reports generation
  • Cloning of submission to multiple countries/applications
  • 21 CFR Part 11 with CMO/CRO/OCL compliance tracking
  • Assure submission readiness through Pre-XML validation
  • Dossier-acknowledgement repository with email notification
  • Easy Import of legacy submission in NextGen eCTD Software with LCM

Unique benefits
  • Effective workflow which reduces 40% publishing time
  • One stop solution for all eCTD publishing activities
  • Dossier tracking helps during health authority inspection
  • Cloud version reduce 3⁄4 part from maintenance cost
  • Parallel working - multiple users, countries, applications and locations

Artixio’s eCTD Software on Microsoft Azure Cloud

  • Intended for both cloud (access from anywhere) and in-house deployment
  • Robust cloud version (MS Azure) with data encryption and firewall security
  • Auto live data backup (60 min) and data disaster recovery
  • No higher IT infrastructure (software and hardware) required
  • Separate encrypted database and storage for each client

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