We’re pleased to announce that iSafety Systems has joined ProPharma Group.

Together we are forming the world’s leading provider of pharmacovigilance services for clients seeking strategic solutions and comprehensive drug safety support from clinical through post-approval. Learn about our expanded services.

Global Labeling and Company Core Data Sheets (CCDS)

End to end Labeling and CCDS services

Company Core Data Sheets (CCDS)

CCDS is a core central internal regulatory document prepared by the Marketing Authorization Holder (MAH) containing information pertaining to indications, dosing, pharmacology and other information concerning the marketed pharmaceutical or biological product in addition to safety information.

The concept of a CCDS was proposed by CIOMS guideline to provide reliable and consistent data across the markets globally, as it is necessary to ensure patient safety and should be accepted world wide.

The core purpose of CCDS is –

  • To harmonize the safety information of any drug product across the globe and contains regulatory authority-approved information on the respective product.
  • To have updated and accurate “Reference Safety Information” in order to carry out all the Pharmacovigilance activities.
  • To judge whether an adverse event or adverse drug reaction is labeled / listed or unlabeled / unlisted for the product, this is required for the regulatory processes.

Global Label Management and CCDS Services

At iSafety, unique hybrid templates are customized and implemented as per the customer policies and goals.

To cater the regulatory needs and harmonize all the labeling requirements globally, we provide Global label and CCDS services;

  • We create Company core data sheets and DCDS, SmPC, RSI as per company SOPs and procedures and can create customized solutions for company requirements
  • We do different labels and Brand leader comparisons and Local label reviews for common information and standards
  • We update the Safety updates/triggers from health authority (PhVWP, PRAC, CSPs, Article Referrals, Health Authority websites) along with pre & post approval regulatory labeling support.
  • We cover Scientific Translation of CCDS/SmPC/RSI/Label to meet local regulatory needs based on the MAH requirement
  • We compile regional labeling documents: USPI, PM (Canada).
  • We compile and design Prescriber Information (PI) for physicians & Patient Information Leaflets (PILs) for patients, Summary of product characteristics (SmPCs) for health care professionals

Label Artwork Services

  • Artwork Centralization
  • Creation and Design of Mockups and PGDTs
  • Artwork Creation (Label, Foil, Carton, Promotional Material)
  • Proofreading in multiple languages
  • Implementation of Artwork Changes In line with Regional Regulatory Requirements
  • Development and Maintenance of International Product Information
  • General Export Packs Updates

iSafety team comprises of experts from Global Labeling, Chemistry, Clinical/Medical Affairs, Pharmacovigilance/Drug Safety, Pharmacokinetics and Pharmacodynamics (PKPD) functions and also legal and marketing for special cases.

Quality checklists based on sections of CDS/PIL/USPI /SmPC documents are in place, along with compliance metrics. Monthly complex conventions/updates and weekly quality discussion with MAH-iSafety SST (Safety surveillance team) helps us achieve 100 % compliance with great quality.