Prescription Drug Labeling

Prescription Drug Labeling

USA

• Preparation of Prescribing Information (PI), Patient Information Leaflet (PIL), Medication Guide (MG), and Instructions for Use (IFU)
• Preparation of side-by side (SBS) Labeling and Label comparisons
• Preparation of Labeling Quality-based-Review (QbR) document
• FDA Deficiency Response Management
• Continuous Monitoring/ Tracking of the Reference Listed Drug (RLD) Labeling
• Updating Generic Product Labeling as per Safety or Non-Safety changes approved for the RLD Labeling
• Preparation of Labeling History document for tracking the changes in labeling throughout the life cycle
• Preparation of Labeling Changes Summary for Annual Reports

Europe

• Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labeling text (LT)
• Preparation of Annexure 1, 2, 3 & 4 in accordance with Quality Review of Documents (QRD)
• Co-ordination of EU Linguistic review activity
• Visual Quality Control (QC) of different translated labeling documents in line with English text.

Canada

• Preparation of Product Monograph (PM), and Patient Medication Information (Part III)
• Preparation of Annotated and Non-Annotated Product Monographs
• Continuous Monitoring/ Tracking of Canadian Reference Product (CRP) Product Monographs that have any impact on clients approved or pending products
• Preparation of Notifiable Changes (NC) submissions in case of Safety changes as per CRP updates for Generic Drug Products in accordance with the “Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy” document to reflect the Plain Language Labeling Regulations.