Blog & Article
- 18th April 2024
White Papers
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.
White Paper
According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.
White Paper
It is estimated that over 80% of prescribed medicines in the UK are generic medicines, yet they account for only one-third of the total market value. Why?
White Paper
Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
White Paper
Download our recent whitepaper to gain deep insights into the Medical Literature Monitoring of the EMA.
White Paper
Download our recent whitepaper to gain deep insights into the Monitoring Compliance with Safety Exchange Agreements.