IntroducingNextGen SPL software.

Robust Automation for Seamless SPL Conversion and Compliant HL7 SPLR4 XML Processing.

Available For Cloud | Server

Nextgen SPL Supporting Country


Empowering Pharma Industries with a Robust Platform for SPL Conversion and Validated HL7 SPLR4 XML Generation, Ensuring USFDA Compliance

Maximize Efficiency

Experience an effective workflow with single page functionalities that significantly reduce processing time by up to 40%.

All-in-One Solution

Simplify your regulatory submissions for Rx, OTC, and Cosmetics products with a comprehensive software solution catering to eCTD submission and Drug Listing requirements.

Pre-Defined Templates

Utilize pre-defined templates designed for different types of SPLs, including PLR, Non-PLR, and OTC products, ensuring compliance and ease of use.

Collaborative Environment

Facilitate parallel working by enabling multiple users, projects, and locations to collaborate seamlessly within the software.

Anytime, Anywhere Access

Benefit from the web-based software, granting you the flexibility to access it from any location and at any time, promoting convenience and productivity.

Cost-saving Cloud Versions

Opt for the cloud-based versions to significantly reduce maintenance costs by up to 75%, allowing you to allocate resources more efficiently.

Robust Security Measures

Rest assured with a secure cloud version that implements data encryption and firewall security, safeguarding your valuable information.

Automatic Data Protection

Enjoy peace of mind with auto live data backup and data disaster recovery features, ensuring the integrity of your data.

Simplified Implementation

No need for extensive IT infrastructure; the software offers a hassle-free setup, minimizing implementation complexities.

Client-specific Security

Maintain confidentiality with separate encrypted databases and storage dedicated to each client, ensuring data security and privacy.

NextGen SPL Features

Empowering Efficient & Accurate Drug Product Labeling

NextGen SPL (Structured Product Labeling) offers advanced features for streamlined and accurate drug product labeling. Enhance compliance, reduce errors, and simplify the process with our cutting-edge SPL solutions.


Comprehensive Dashboard

Track scheduled and overall SPLs with an effective dashboard that provides users, admins, and management at different levels with a single-click view of activities, including total SPLs, upcoming SPLs, and SPL status.


Guidance-Specific Auto Validation

NextGen SPL software ensures error-free creation and processing of various SPLs (PLR, Non-PLR, OTC, Cosmetics) by implementing guidance-specific auto validation at each stage.


Seamless Inheritance of Versions

Maintain flawless life-cycle management of SPLs by automatically inheriting DLD, PDP, and COL sections from previous versions using NextGen SPL software.


Efficient SPL XML Review

Review SPLs within the software in XML format and using popular web browsers like Internal Explorer/Microsoft Edge, enabling effective evaluation and validation.


Easy Cloning

Simplify the management of multiple strengths and packaging configurations for the same product with NextGen SPL software's cloning functionality. Clone and create new SPLs, especially useful for multiple labelers.


Formatting-Friendly Content Copying

Copy content from different file formats such as Word and PDF without any formatting disturbance, preserving styles like bold, italic, underline, and more, with the NextGen SPL software.


Central Repository with Advanced Filtering

Manage and track all SPL projects seamlessly using the NextGen SPL software's central repository. Utilize various filters including Set ID, NDC numbers, Labeler, Approved OR Unapproved, and more for efficient organization.


Effective Content Editing

NextGen SPL software features an efficient content/text editor that supports multiple styles such as hyperlinking, table creation, images placeholder, and various font types (bold, italic, underline), along with special characters.


Migration and Lifecycle Management

Migrate/import legacy SPL projects, including multiple versions, or single versions easily using the automated Import functionality of NextGen SPL software, ensuring smooth transition and lifecycle management.


Dossier-Acknowledgment Repository with Email Notifications

Automate communication with cross-functional teams by leveraging email notifications for successful SPL submissions to health authorities in eCTD submissions and/or drug listings. Maintain a repository for submission acknowledgments, streamlining the process.

Built with Regulatory specifications, validation, and compliance.

Our software ensures efficient management of SPL life cycles, including version control, and guarantees complete validation according to FDA specifications. With our reliable day-to-day service, we provide a seamless experience for our clients.

USFDA and HL7 standards

USA (USFDA) SPL Conversion

• Guidance: Drug Establishment Registration & Listing

• Implementation Guide: Validation Procedures V 1.0

• Instructions: Drug Establishment Registration & Listing V 2.0

• Active Ingredient: Active Moiety Relationship/Basis of Strength

Choose the Right Plan for Your NextGen SPL Software

No matter the size of your organization, our plans are designed to meet your specific needs and streamline your SPL conversion and management process. Choose the plan that suits your requirements and start maximizing efficiency and compliance today.

Annual Subscription
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  • 1 User
  • Migration of Legacy SPL's: ≤ 10
Annual Subscription
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  • 2+ Users
  • Migration of Legacy SPL's: ≤ 25
Annual Subscription
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  • 5+ Users
  • Migration of Legacy SPL's: Unlimited

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