PHARMACEUTICAL REGULATORY AFFAIRS
SmPC, PIL & Labelling
Regulatory preparation and review of medicinal product information.
SERVICE 06
Summary of Product Characteristics
We support drafting, review and updating of SmPC content to reflect the authorised product, supporting dossier information and applicable UK or EU regulatory templates and guidance.
Patient Information Leaflet
PIL support includes readability-focused regulatory review, consistency checks with the SmPC and alignment with relevant product information templates.
Labelling and change control
We review proposed labelling text, container and outer-pack particulars and the regulatory impact of product information variations.
Specialist activities
Formal user testing, translation, Braille production and packaging artwork creation are separate specialist activities and are not included unless expressly agreed.
Typical support activities
- SmPC drafting and regulatory review
- PIL preparation and SmPC/PIL consistency assessment
- Labelling text review
- Template and QRD alignment checks
- Product information updates for lifecycle submissions
Services and deliverables are subject to a project-specific scope of work and the relevant regulatory framework.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.