Electronic Publishing & Submission Management

AARIYA with an extensive eCTD track record has the expertise necessary to successfully manage your electronic submissions in an efficient and cost-effective manner

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Electronic Publishing & Submission Management

As more and more global Heath Authorities are now asking for submissions in the electronic format, the need of the hour is to deploy robust publishing tools to manage region-specific formats.

AARIYA provides dossier publishing & submission services worldwide of utmost quality, supporting both eCTD and Non-eCTD electronic Submission (NeeS) formats. All submissions are compiled as per the Agency specific format using the updated DTD versions. Our experts have diligently curated a double vetting process for the Technical Quality Review of documents which is powered by both our expertise and robust software validators that guarantees an error-free process for your submission.

All submission services are supported by our experienced regulatory publishing team, whose deep knowledge of local and regional guidelines can help streamline your end-to-end submission management process, through:

  • Document level publishing by hyperlinking, bookmarking, formatting and converting files to the necessary standards.
  • eCTD population and publishing
  • Checklist-based validation of documents (which includes verification and correction) as per the specifications laid down in the Agency’s Validation Criteria
  • Document and Submission levels Quality Check (QC)
  • Legacy paper management and conversion to NeeS to eCTD
  • Conversion of DMFs to eCTD
  • eCTD lifecycle management for continued support to all future sequences of your application
  • Electronic Submission Gateway (ESG) services for securely transmitting submissions to the Agency using authorized submission portal

Apart from deploying experienced Regulatory personnel, AARIYA uses one of the world’s leading publishing software, eCTD Office™, for the creation, validation and publishing of regulatory documentation for electronic submissions of your products – Drugs, Biologics, and Medical Devices.


Vision

To become a noble regulatory consultancy, delivering high quality regulatory support to clients for introduction of wide range of generic and branded products in the market.

Mission

We thrive to provide quality focused and flexible services to the utmost satisfaction of our clients building long-term relationship.

Values

Success and strength of any company rests on its strong beliefs and values. We believe in Customer service excellence, Uncompromising quality, Ethics and integrity

Our Client’s Testimonials

    Manager-Regulatory AffairsHead of Regulatory Affairs
  • Aariya’s seamless support in arranging quality labeling, technical inputs, quality review, and most importantly their short turn-around time helped us in timely response to the FDA thereby assisting in securing faster product approval.
    Manager-Regulatory Affairs
    A Malaysian Based Generic Pharmaceutical Company
  • They are great with their prices and excellent with their turn-around times. The most important quality that I like about Sachin and his team is that they would go that extra mile to get the job done and have so far never let us down.
    Head of Regulatory Affairs
    A US Based Generic Pharmaceutical start-up