The role of PLG’s regulatory operations services in the registration process
Regulatory operations can be complex and time-consuming. Our regulatory operations unit provides a full range of services to ensure your products are ready for registration and maintained in full compliance following approval. We also cover how your company manages its regulatory data, ensuring it remains under your control while complying with the regulations for integration with health authority systems.
These operational services work in tandem with our dedicated regulatory affairs services group throughout the product’s life cycle.
PLG’s regulatory operations domain contains five main services:
Regulatory Information Management System
Improve the management of your data and documents to be ready for the digitalization of regulatory affairs
Publishing
Formatting and publishing your dossier to follow local and global standards and delivering them to the authorities via portals
Readability Testing
Ensuring your patient information leaflet (PIL) is compliant and comprehensive
Labeling
Worldwide, customized regulatory-labeling support across the product lifecycle
Translations
Multilingual support for your global needs