Blog & Article
- 27th April 2025
White Papers
White Paper
Growing regulatory complexity and mounting cost pressures mean that biopharmaceutical companies can struggle to sustain post-launch product revenue streams in today’s hyper-competitive global markets. More than ever, organizations are looking to strategically outsource the regulatory lifecycle management of their established products to help manage compliance risk and reduce costs, freeing up key internal personnel to focus on strategic projects.
White Paper
In the rapidly evolving world of regulatory requirements, navigating local affiliate pharmacovigilance can be challenging. Our expert guide provides you with detailed frameworks, insights, and best practices that are helping biopharma companies establish and maintain compliance with these complex requirements.
White Paper
This whitepaper explores the hype versus the current reality for AI technologies within pharmacovigilance and examines the main business use cases today plus the potential gains for biopharmaceutical safety teams. We provide a decision guide to help assess whether an AI approach is appropriate, or whether more established methods with demonstrated benefits – such as rules-based automation – are better suited for the job at hand.
White Paper
Targeted medicines represent a class of treatments designed to specifically target individual disease conditions such as molecular or genetic alterations that drive disease progression. Unlike traditional therapies, which typically have broad effects on both healthy and diseased cells, targeted therapies aim to selectively address the aberrant signaling pathways or biological processes underlying a particular disease or disease subgroup.
White Paper
In this panel discussion hosted by PharmaLex, industry experts discuss biosimilars’ progress, what’s on the horizon, the regulatory climate and strategies to increase biosimilar uptake.
White Paper
Project Orbis is an international collaborative e-framework initiated by the United States (US) Food & Drug administration (FDA) Oncology Center of Excellence (OCE) in May 2019. It was created to achieve one main objective, which is to facilitate the submission, review, and approval of oncology medicinal products. This framework allows concurrent submission and review amongst the Project Orbis Partners (POPs).
White Paper
As the pharmaceutical industry continues to globalize, operational agility is critical to staying in step with a rapidly evolving regulatory environment without jeopardizing quality and compliance. Regulations have grown increasingly stringent and undergone significant change in the past several years. And data and documentation requirements have become increasingly strict and complex — all along the product development lifecycle.
White Paper
Globalization has broadened opportunities for companies to make their products available to more people in more markets, while at the same time ensuring patients in emerging markets have access to products that can change or even save lives.
White Paper
Before undertaking a validation attempt of an analytical method, it is important to think about the experimental design. In this white paper we go into some theoretical aspects and requirements needed to estimate the optimal experimental design from a cost vs. risk perspective. As a starting point and principle we use the Total Analytical Error (TAE) which we believe is the future of analytical method validation, and which is also slowly getting its way into the governing guidelines of analytical method validation such as ICH Q2(R2), ICH Q14 and USP <1220>.
White Paper
Integrated product development (IPD) is a strategy that promotes the integration of multidisciplinary teams as part of the development process. It leverages a holistic approach to achieve key objectives of improved efficiencies, shortened timelines and reduced costs in bringing a product to market succeeding by involving all functional team members early in the development process.
White Paper
In the face of dwindling drug pipelines, complex regulations and block-busters crossing their patent exclusivity, mature products offer a revenue stream for companies to sustain their bottom lines in a hyper-competitive global market.
White Paper
Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these activities.