The role of PLG’s regulatory operations services in the registration process

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
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Publishing

Formatting and publishing your dossier to follow local and global standards and delivering them to the authorities via portals
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Readability Testing

Ensuring your patient information leaflet (PIL) is compliant and comprehensive
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Labeling

Worldwide, customized regulatory-labeling support across the product lifecycle
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Translations

Multilingual support for your global needs
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Be assured that your products will be in the hands of experts throughout their entire lifecycle.

Philip Smith

Head of Regulatory Affairs Services, ProductLife Group

Philip Smith, Head of Regulatory Affairs Services, ProductLife Group