Regulatory Labeling Services

As a leader in the Regulatory labeling domain, we provide end-to-end services to ensure labeling compliance. Our experts streamline the varied labeling processes by harnessing the power of Artificial Intelligence. Trust us to meet your evolving business needs.

  • 180

    +

    Experts
  • 13000

    +

    Labels Processed Annually
  • 50

    +

    Customers/Clients
  • 1000

    +

    CCDS/ CCSI and CO/JD
  • 5000

    +

    XML Conversions
  • 1500

    +

    Remediations
  • 3000

    +

    RPI Updates
  • 4000

    +

    Core to Label Alignments
  • 99

    %

    Compliance

Regulatory Labeling Services - Overview

Freyr offers end-to-end drug Regulatory Labeling Services and software support for global and regional Regulatory labeling management, providing professional assistance in drafting Investigational Brochures (IB), Developmental Core Data Sheets, and Developmental Core Safety Information, creating and updating Company Core Data Sheet (CCDS), core to local product labeling requirements, etc.

Our team of highly qualified medical experts tracks the status of the data sheets’ implementation in local labels, reviews and suggests changes to the data sheets, and drafts the clinical overviews of product labeling requirements for submission to the health authorities.

Freyr's expertise ensures labeling compliance and navigates the complexities of labeling in Regulatory Affairs. We also provide content to carton services for seamless and compliant packaging.

Our CCDS template streamlines the process, facilitating efficient management of core data sheets and local product labeling requirements. Additionally, we harness the power of Artificial Intelligence in Regulatory Labeling Services to enhance accuracy and speed in datasheet implementation and review. With precision and Regulatory adherence, our comprehensive services cater to the evolving needs of the pharmaceutical industry.

Regulatory Labeling Services

  • End-to-end drug Regulatory Labeling Services and software support
  • Drafting Investigational Brochures, Developmental Core Data Sheets, and Safety Information
  • Creating and updating Company Core Data Sheets (CCDS)
  • Comprehensive services for global and regional Regulatory labeling management
  • Expert review and suggestion of changes to company core data sheets
  • Drafting clinical overviews and non-clinical overviews to support label changes
  • Utilizing Artificial Intelligence to enhance accuracy and speed in labeling
  • Ensures labeling compliance across global Regulatory standards
  • Seamlessly manages core to local product labeling requirements
  • Tracks status of data sheet implementation in local labels
  • Provides precise and Regulatory-adherent content to carton services
  • Streamlines CCDS process with an efficient template
  • Offers comprehensive solutions catering to the pharmaceutical industry's needs
  • Navigates labeling complexities in Regulatory Affairs with expertise
  • In-house software and system solutions for labeling compliance and tracking of (Document Management Systems (DMS)

Connect for End-to-end Labeling Services

Success Stories

: Freyr Ensured Regulatory Compliance and Efficiency for a European Multinational Pharmaceutical Company Across the US and RoW Regions, Resulting in Successful Labeling Compliance
Labeling

Freyr Ensured Regulatory Compliance and Efficiency for a European Multinational Pharmaceutical Company Across the US and RoW Regions, Resulting in Successful Labeling Compliance

A European multinational pharmaceutical company needed to ensure Regulatory compliance and efficiency across the US and RoW regions for their numerous antibiotic products. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr had created and reviewed ANDA labeling components, delivering compliant, submission-ready documents. This streamlined partnership resulted in 100% right-first-time submissions and eliminated "Refuse to File" instances.

Freyr Ensured Regulatory Compliance for a Leading Biopharmaceutical Company Through Comprehensive Text Review and Formatting Support
Labeling

Freyr Ensured Regulatory Compliance for a Leading Biopharmaceutical Company Through Comprehensive Text Review and Formatting Support

A leading biopharmaceutical company faced the challenge of ensuring Regulatory compliance and enhancing the readability of various labeling documents across multiple regions. They had turned to Freyr for comprehensive text review and formatting support. Freyr meticulously supported the client, resulting in high-quality, submission-ready documents that ensured Regulatory compliance.

Freyr Ensured Seamless Labeling Transition for Over 1500 Artworks for a US-Based Leading Pharmaceutical Manufacturer During Site Transfer and Name Change Activities Through Extended Support
Labeling

Freyr Ensured Seamless Labeling Transition for Over 1500 Artworks for a US-Based Leading Pharmaceutical Manufacturer During Site Transfer and Name Change Activities Through Extended Support

A leading US-based pharmaceutical manufacturer had faced challenges in updating over 1500 artworks to meet Regulatory standards during site transfer and name change activities. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr ensured a seamless labeling transition, resulting in zero Refuse to File instances and quick turnaround times.

Freyr Ensured Regulatory Compliance and Managed Queries Efficiently for a USA-Based Generic Pharma Company with Complex Molecules Through Labeling Support
Labeling

Freyr Ensured Regulatory Compliance and Managed Queries Efficiently for a USA-Based Generic Pharma Company with Complex Molecules Through Labeling Support

A USA-based generic pharma company, dealing with complex molecules across multiple therapeutic areas, had faced Regulatory challenges with an active product portfolio. They had turned to Freyr for comprehensive end-to-end labeling support. Freyr ensured Regulatory compliance and efficiently managed queries, significantly enhancing the company's Regulatory compliance and operational efficiency.

Freyr Ensured Compliance with Health Canada's New Guidelines for a Leading Canada-Based Generic Manufacturer Through Comprehensive Regulatory Labeling Support
Labeling

Freyr Ensured Compliance with Health Canada's New Guidelines for a Leading Canada-Based Generic Manufacturer Through Comprehensive Regulatory Labeling Support

A leading Canada-based generic manufacturer needed comprehensive support to comply with Health Canada's new guidelines across multiple therapeutic areas. Facing organizational challenges and outdated templates, they had turned to Freyr for assistance in updating and creating compliant labeling documents. Freyr provided support that integrated the latest requirements, resulting in fast, efficient, and accurate labeling updates.