End to end Labeling and CCDS services
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 –
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;
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.
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