Overview

Purpose of LabelingAs a critical aspect of product lifecycle management, labeling is considered as one of the complex processes of life sciences’ regulatory environment. It includes regulating multiple documents that define the data elements needed on the product labels. Product Labels are targeted at diverse audiences such as patients, physicians, and pharmacists. In addition, product labels need to  comply with stringent Health Authorities’ (HA) mandates.

Due to constantly evolving regulatory requirements, organizations must ensure the product information related to manufacturing, safety and efficacy included on the labels is controlled by maintaining a central/core reference product information.

Regional labels are aligned to the updated Company Core Data Sheet (CCDS) information and are written in the native language of the relevant country/region where the products are registered. In such scenarios, the challenge for organizations is to decode the region-specific drug labeling rules, to track the updated CCDS templates and to integrate them without affecting the product’s safety information.

Freyr is a strategic global partner for labeling change management and helps its clients navigate through the complex labeling processes with an end-to-end labeling Center of Excellence. Freyr’s experienced labeling team not only tracks the country-specific labeling standards for timely implementation of the labeling changes, but also provides cost-effective labeling coordination for Innovators, Generics, Consumer, Biosimilars, Biotech, Medical Device and Food/Dietary sections.

 

Freyr Capabilities

Global Labeling Management

  • Writing/updating Company Core Data Sheet (CCDS)/Company Core Safety Information (CCSI)
  • Drafting the supporting documentation (Clinical and Non-clinical Overviews)
  • Tracking and implementation of core label update to regional product labels
  • Regulatory labeling intelligence

Regional Labeling Management

For US, EU, LATAM, JAPAC (AUS & NZ), RUSSIA CIS, AFRICA, and MENA:

  • Preparation of Regional Prescribing Information (RPI) & Patient Information leaflet (PIL) for Marketing Authorization Application, Variations/Supplements & Renewals
  • Aligning Core Data Sheets with regional labels and vice versa: Identifying & reviewing deviations between CDSs and regional labels to find out safety impact for change recommendations
  • Health Authority Query Management

For the US:

  • Structured product labeling (SPL, an HL7- and ANSI approved standard) submissions to FDA

Audit & Compliance

  • End-to-end auditing of the labeling process to ensure Quality Compliance
  • Proposing solutions and methodology to implement Health authority audit remediation activities
  • Driving efficiency for label gap analysis, remediation plans, and deviation tracking
  • Implementation of safety changes into market labels including metrics reporting and maintenance

Technology

  • Labeling Repository: To store and archive the CDSs, regional/national labels and supporting documents
  • Labeling Tracker: To track & check the status of the data sheet changes and implement them in regional/national labels
  • Document Manager: To track the status of various milestones (e.g. writing, review, approval etc.) across lifecycle
  • Fully configurable labeling & artwork management software

Translation & Proof Reading

  • Translation capabilities of multilingual labels to English and vice versa
  • Thorough proofreading (manual/electronic) of the labels for maintaining consistency and high quality of language
  • Visual quality check of translated labels
 
 

Freyr Advantages

  • Resources with in-depth Regulatory knowledge perfectly integrated with IT capabilities
  • Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients, worldwide
  • Extensive global experience covering diverse Regulatory domains across Pharma
  • Highly qualified medical writers possessing extensive Regulatory experience
  • Regulatory expertise in CTD Module 1 to Module 5
  • In-depth and updated understanding of the global drug labeling changes as required by local regulatory authority bodies
  • Dedicated compliance team tracking the status of the data sheets implementation in regional labels
  • Highly experienced 100+ labeling professionals
 

End-to-end CCDS Update Ensured With Introduction of Working Instructions Document (WID)

Freyr successfully prepared WID for seamless Process Standardization providing round-the-clock support to the CCDS update/development.
Download
 
Freyr LABEL

Freyr LABEL

Freyr LABEL is a complete information management solution to streamline the Regulatory Labeling practice of any size in a company. Right from tracking and managing CCDS deviations, CCDS updates and development to creating and implementing local labels as well as custom reporting, Freyr Label is an end-to-end solution that puts companies in total control of all their Labeling compliance needs.

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CLIENT TESTIMONIALS

 
  • During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

    President,
    An Independent regulatory and quality consulting company

  • Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

    Project Manager,
    A full-service Clinical Research Organization (CRO)
    Based in Florida

  • We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

    – VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

  • We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

    We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.

    – Vice President, Clinical Research & Pharmacovigilance, Microlabs

  • It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

    I look forward to returning to work with you in January and an exciting new chapter in our time.

    – GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

  • We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

    I would like to thank the entire team for their support for critical XEVMPD compliance activities.

    Program Manager, Global Top 5 Pharma and Consumer Health Company

  • I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

    Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

    - Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

  • As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

    We recognize and acknowledge the exemplary performance and look forward to working together.

    – Manager, Regulatory Operations, Global Top 20, $20+ Bn,
    Pharmaceutical Company

  • Great company for eCTD and regulatory outsourcing is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.

    - Associate Director, Regulatory Technology and Ops,
    Global Top 20 Pharmaceutical Company