White Papers
White Paper
- September 26, 2022
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
- June 24, 2022
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
- June 14, 2022
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
- January 10, 2022
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
- July 30, 2021
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
- July 30, 2021
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
- July 12, 2021
Download our recent whitepaper to gain deep insights into when your notified body is losing its designation under the medical device regulation and how to effectively prepare for the change.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into the top tips for a successful EU Orphan Drug Designation application.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into the Medical Literature Monitoring of the EMA.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into the Monitoring Compliance with Safety Exchange Agreements.
White Paper
- July 12, 2021
Download our recent whitepaper to gain deep insights into the Implementation of Eudravigilance Data Analysis System (EVDAS) in signal detection.