LIFE CYCLE MANAGEMENT
An integrated approach and guidance for life cycle management of your products
Efficiency and compliance through the entire product life cycle
PLG life cycle management (LCM) services offer a unique value proposition to pharmaceutical and life science industry clients. We work as an extension of your team, allowing you to focus on your core business activities while we navigate the complexities of life cycle maintenance. Our integrated services cover all stages in life cycle management, from regulatory affairs and operations, safety, and vigilance to quality and manufacturing compliance. We ensure a comprehensive approach with a cohesive team working on various activities, leading to cost savings and efficiency. We stand out by providing the right expertise at the right place and the right cost for effective project management. Our services extend to the global management of established and innovative product portfolios.
Regulatory affairs and operations
With our extensive experience, our team covers the full suite of regulatory affairs, regulatory operations, and CMC services from development to the final stage. Our commitment is to support you globally, bringing you the best solutions for managing all projects.
Quality and compliance
PLG ensures your company’s adherence to Quality and GxP regulations for safe and effective product development, offering a comprehensive suite of services from facility design, Qualification / Validation, QMS setup and implementation to Quality Assurance documentation management
Safety and vigilance
From the clinical development phase to marketing authorization and beyond, our services safeguard medicinal product safety and efficacy throughout their lifecycle. Our team of global vigilance experts offers a complete solution to ensure regulatory compliance and operational efficiency.
Global reach with local expertise in life cycle management
At PLG, our work demonstrates our commitment to providing excellence and efficiency in the pharmaceutical and life science industry. Over the years, we have consistently adapted to offer strategic insights and navigate ever-changing regulatory requirements, proactively preparing to implement new regulations. We align seamlessly with our clients’ strategic business priorities with an efficient and reliable project management methodology using a winning combination of expertise and experienced teams. With over 30 years of experience and a global reach, we stand as a trusted partner of our clients, ensuring regulatory compliance of their existing and new product portfolio.
KEY FIGURES
8+
Global regulatory life cycle maintenance outsourcing programs using central/local outsourcing model consisting of an average of 35+ countries and an average 50 headcount.
98%
We consistently meet a 98% success rate for timely cases submitted to agencies and health authorities within 15 days for serious cases and 90 days for non-serious global compliance.
100%
Percentage of success rate for clinical trial submission to agencies and health authorities.
90+
Projects in computer system validation and data integrity projects across 40+ clients across various EU countries.
Central and Local-Global PV Outsourcing Solution
Whether a long-term partnership for a complete solution or a selection of activities, our comprehensive global delivery model supports you with optimized pharmacovigilance activities, ensuring the safety of your products.
Central and Local-Global Regulatory Outsourcing Solution
PLG provides a comprehensive regulatory services package for biopharmaceutical companies. Our extensive experience ensures the product portfolio’s seamless transition, roll-out, and maintenance, ensuring product continuity and regulatory compliance.
Facility Engineering & Construction Solution
We help pharmaceutical companies ensure they meet the highest quality, safety, and compliance standards. Our offerings include facility design and construction, process engineering, qualification and validation (including Computer System Validation), and Energy and Waste management services across a spectrum of industries, with the highest level of customization.