Watch the replay of our webinar on the 4 Key Pillars for RIMS Implementation

Discover the best practices and tools for building a solid foundation for your RIM System with our Principal Consultant RIM/IDMP, Catherine Gambert and our RIM Officer, Debborah Bamouh. During this session, our experts explored how to select the best tools, how to redesign processes, how to ensure high data quality and how to onboard users’ community and keep momentum.

ProductLife Group acquires Intexo Societa Benefit, strengthening its market access and regulatory strategy offering

PLG is thrilled to announce the acquisition of Intexo, a consulting firm providing integrated market access and regulatory affairs services. This strategic acquisition will empower PLG to strengthen further its capabilities in all the phases of drug development, including access strategies, health economics evaluations, and pricing and reimbursement, thus optimizing access to highly innovative products.

ProductLife Group acquires Strategiqual, reinforcing its position as quality and regulatory leader on the French market

With its extensive knowledge of European regulations and French specific national requirements, Strategiqual’s team provides support to pharmaceutical and medical device companies to ensure product and organizational compliance. The company benefits from unique regulatory know-how, consolidated by close partnerships with institutional stakeholders, professional organizations, incubators and universities.

Real-World Data (RWD) and Real-World Evidence (RWE) to support regulatory decision-making

Explore the fantastic potential of Real-World Data and Real-World Evidence in shaping drug regulatory decisions.
Learn how these tools complement Randomized Clinical Trials and navigate USFDA guidelines for non-interventional studies, data transparency, and sponsor responsibilities

Use of mobile scanning for labels and Package Leaflet (PL), improving accessibility to medicinal Product Information

An ever-present tool in our daily lives is technology. Our smartphones, tablets, laptops, and other technologies are always an arms reach away. We use these tools to keep educating ourselves consistently. This action is no different when we are shopping for our medications. The pharma industry is adapting to these consumer behaviors. Let PLG take you on a journey through some of the changes coming to the EU. These changes will impact pharma companies registering their products with new forms of media to be added to the dossier in the labeling and Package Leaflets sections.

Regulatory Intelligence Monitoring in the ever-changing regulatory environment

The competitive pharma industry and dynamic changing regulations allow for a thin margin of fault for all pharma companies. You have to always be on top of your game, and as many pharma experts in the business will tell you, you also need to be ahead of the game. This phenomenon is not unique to the pharma industry, and many other global industries experience this. How do they maintain their superiority in this global market? Intelligence. In the pharma industry, you must have quality information at your fingertips to stay ahead of the game and make efficient decisions.

Best practices for National Phase Management in EU post-MRD/DCP

Time is crucial in certain stages of the medicinal product registration process. It becomes pertinent to plan for certain aspects of the process. In this article, we will delve into the importance of best practices in National Phase Management and how they can impact the promptness of your submissions of National Phase Product Information Translations and mockups. Also, are there regional criteria you should be considering? Trust PLG to support you in the timely and accurate submission of your Product Information and packaging during the National Phase of product registration.

Biosimilars in LATAM: an overview

The Latin American (LATAM) market is one of the fastest-growing markets in the world. The essential ethos and responsibility of pharma companies is to provide medicinal solutions to the general public and improve healthcare. LATAM is a region and, more importantly, a group of countries coming together to embrace pharma companies. These countries continue to work together to improve the conditions for pharma companies to register and make their products available to the public.

Navigating the future of regulatory compliance: EMA's web-based EAF update

ProductLife Group is thrilled to share EMA’s latest update on web-based Electronic Application Forms (eAFs)! Key milestones for Q1 2024 include IDMP-compliant Centrally Authorized Products (CAPs) and National Authorized Products (NAPs) for variations of eAFs. This move promises streamlined processes for applicants and regulators, marking a significant leap in efficiency.

Healthcare transformation: AI/ML-Driven medical devices and future opportunities

We once looked at Machine Learning (ML) and Artificial Intelligence (AI) as pure science fiction from the movies. It is 2023, the technology has grown from the minds of geniuses and is becoming more of a reality as the days pass. Integrating this new tech in the medical industry places us on the cusp of a new frontier. Just like the past frontiers, we must approach with enthusiasm and caution. Caution involves limits, and the world’s Health Authorities define those limits. Discover what the global health authorities are up to regarding legislation regulating ML/AI in Medical Devices, from the first ever “AI Act” in the EU to “Good Machine Learning Practices (GMLP)” being defined by a combination of the US, UK, and Canada.

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October 2023 Monthly Newsletter