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Our white papers and technical bulletins are written by industry experts from many different fields, exploring and commentating on a range of complex subjects.

Nitrosamine Control: Understanding the New FDA and EMA Regulations Nitrosamine Control: Understanding the New FDA and EMA Regulations

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and our proposed risk assessment method for compliance.

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SGS HN ISO Sunscreen Guidelines A Guide to the Requirements and Changes to ISO 24444:2019 – In Vivo Determination of the Sun Protection Factor (SPF)

On December 19, 2019, a new edition of ISO 24444 – in vivo determination of the Sun Protection Factor (SPF) was published. This guide summarizes the requirements and major changes.

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Standard vs. "Hybrid" FIH Trial Advantages and Challenges Standard vs. "Hybrid" FIH Trial Advantages and Challenges

This white paper examines the key considerations to take into account when deciding whether to run a standard first-in-human study in healthy volunteers or a hybrid FIH clinical trial.

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Convergence of Rewet Data in Nowadays' Baby Diapers Convergence of Rewet Data in Nowadays' Baby Diapers

This update aims to provide more information about how SGS uses rewet data (following ASH-R methods) to test nowadays' baby diapers.

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CE Marking of Construction Products, Today and Tomorrow

This white paper is intended for anyone who deals with CE marking of construction products and wants to know more about the applicable regulations for these products.

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A Guide to Successfully Navigating China's New Cosmetics Import Regulations A Guide to Successfully Navigating China’s New Cosmetics Import Regulations

As of May 1, 2021, global cosmetic brands looking to sell their products in China will have to abide by the new regulations. This guide will explain how you can comply.

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Maxims for Early Phase Trials Maxims for Early Phase Trials

This white paper considers the importance of conducting safe, efficient, and productive early phase clinical trials and the options that are available to developers for study optimization.

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An Updated Approach to Extractables and Leachables Testing per ISO 10993–18:2020 An Updated Approach to Extractables and Leachables Testing per ISO 10993–18:2020

Medical devices must not adversely affect a patient’s safety. ISO 10993-18:2020 outlines how medical device manufacturers can test their products for potentially harmful chemicals leaching from the device materials.

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Nitrosamines: Questioning the Current Analytical Approach Nitrosamines: Questioning the Current Analytical Approach

In recent years, multiple drug products (DPs) have been recalled following the discovery of nitrosamine impurities. We look at current investigative methods and the potential for a more effective analytical approach.

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Cell Substrate Characterization In Vitro-based Virus Detection Methods Cell Substrate Characterization In Vitro-based Virus Detection Methods

This white paper explores how all components of commercial biopharmaceuticals and vaccines must undergo extensive safety testing to demonstrate identity, stability and purity.

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