Overview

Purpose of Labeling

As a critical aspect of product lifecycle management, labeling is considered as one of the complex processes of life sciences’ regulatory environment. Considering the regional language specifications / nuances in Middle East and Africa, a label acts as defining factor for a drug/cosmetic/device’s market entry and success. Targeted at different audience such as patients, physicians, and pharmacists, it should not only include the data elements that is presented in regional language but should also be aligned with the SFDA and other competent health authority’s requirements.

Added to that, regional labels should be aligned to the updated Company Core Data Sheet (CCDS) information and should be written in the native language (Arabic or African) where your products are set to be registered. Organizations must ensure the product information related to quality, safety and efficacy included on the labels is controlled by maintaining a central/core reference product information. In such scenarios, the challenge for organizations is to decode the Middle East and Africa-specific drug labeling regulations and to integrate them without affecting the product’s safety information.

With a strong local presence in UAE,Freyr understands the interdependency of product labelling requirements between middle eastern and African countries. Freyr assists clients for labeling change management as per the geo-specific regulations and helps them navigate through the complex labeling processes with an end-to-end labeling Center of Excellence.Freyr’s experienced labeling team not only tracks the region-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 assists clients to meet the Regulatory labeling needs with respect to the SFDA, EDA, JFDA, Israeli MoH, Oman MoH, Turkey MoH, UAE MoH, and Yemen’s SCDMA.

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

  • All regions: Preparation of Regional Prescribing Information (RPI) & Patient Information leaflet (PIL) for Marketing Authorization Application, side by side label comparisons for 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
  • US: Physicians Labelling Rule (PLR) & Pregnancy lactation labelling Rule (PLLR) Conversions, annotated side by side label comparisons for ANDA Submissions
  • EU: EU-PI preparation (Annex 1 to 3) SPC, PIL & LT; End to End  EU-linguistic review coordination for Centrally approved products

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 Arabic to English and vice versa
  • Thorough proofreading (manual/electronic) of the labels
  • 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
  • Extensive global experience covering diverse Regulatory domains across Pharma
  • Highly qualified medical writers possessing extensive Regulatory experience
  • Dedicated compliance team tracking the status of the data sheets implementation in regional labels
 

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.
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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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