Safety and Vigilance Services
Safe and effective use of medicinal products
PLG creating customized vigilance solutions aligned with our client’s needs
After the medicinal product is approved, lifecycle management is essential to your products. PLG’s expertise supports companies with a customized vigilance service and delivers operational efficiency.
Our global vigilance team comprises experts in clinical safety and vigilance for drugs (Pharmacovigilance), medical devices, food supplements, and cosmetics. It can support you in all matters related to vigilance during the product lifecycle – from the clinical development phase through the period between submission and granting a marketing authorization until the products are marketed or until the marketing authorization exists.
The PLG’s experts collaborate and customize solutions to individual client requirements, ensuring medicinal products’ safe and effective use and regulatory compliance.
PLG’s Safety and Vigilance domain covers the following services:
QPPV and Local Safety Officer/Responsible Person
Medical Information (MI)
Literature Monitoring
Individual Case Safety Report (ICSR) Management
Aggregate Report and Risk Management Plan
Signal Management
Why choose PLG as your Safety and Vigilance partner:
PLG’s team comprises internal and external expert resources
The Safety and Vigilance team comprises scientifically qualified professionals with 5-30 years of industrial experience.
We offer a scalable, customized, validated network of partners readily deployable for increased market reach in case of any specific requirements. PLG’s Safety and Vigilance team collaborates closely with other teams, such as Product Development and Regulatory Affairs, to offer harmonized and continuous services during product development and lifecycle management.
PLG provides a unique delivery model to suit your needs
The workflow describes the tasks with milestones and responsibilities. For exploratory proposals, PLG proposes two different Delivery Models with a corresponding different approach:
Option 1: Strategic Approach – This option is a collaborative approach between PLG and the client in the framework definition. PLG acts as a strategic partner from the client and will work in the client’s process and SOP, including their platform—the local and central model with customized solutions to our client’s needs.
Option 2: Task Approach – This approach follows the client framework, and PLG is only responsible for the defined and agreed tasks, e.g., writing on demand one specific module, e.g., PSUR or signal report.
