As 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.
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
- 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
- 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.
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.