White Papers: 2021

Pharmaceutical and Medical Device Act (PMD Act) and Market Requirements for Japan

It is necessary to comply with the Pharmaceutical and Medical Device Act (PMD Act) when importing and selling medical devices from overseas into Japan. Download our free market access guide to ensure your products comply.

Medical Device Market Requirements for Brazil

Download our free Market Guidance Document for medical device regulatory requirements in Brazil. This guide outlines the compliance assessment steps in accordance with Ordinance 384/2020, the standard for the safety and performance of electronic medical equipment.

WHITE PAPER | Trace Metals Testing and Food Contact Materials

Discover trace metals testing protocols for food contact materials to ensure safety and compliance with global standards.

WHITE PAPER | NIAS Screening for Food Packaging containing Post-consumer Recycled Materials

Explore the screening methods for non-intentionally added substances (NIAS) in food packaging materials made from post-consumer recycled content.

Download The Road to ‘Net Zero’ White Paper

In the urgent fight against climate change, the focus is on halting and not just reducing carbon emissions. With the Paris Agreement's 1.5°C target and 'net zero' goals, businesses and governments face mounting pressure to take action and be accountable for their carbon footprint.

White Paper | Intranasal Delivery of Biologic Therapeutics and Vaccines

Explore the challenges and strategies in the development of biologics for intranasal delivery, focusing on formulation and delivery efficiency.

White Paper: The Importance of Aligning a Pharmaceutical Audit Scope with the Correct Standard

Maintaining compliance and transparency in pharma supply chains is crucial. Quality audits of suppliers are vital to ensure high production standards. Choosing the right industry standard mitigates risk.

White Paper | CAPACITY AND CONDITIONS - STABILITY STORAGE OUTSOURCING CONSIDERATIONS

Learn about the factors that impact pharmaceutical product stability and capacity during long-term storage.

White Paper | CAPACITY AND CONDITIONS - STABILITY STORAGE OUTSOURCING CONSIDERATIONS

Explore pharmaceutical storage stability under various capacity and environmental conditions to ensure product quality.

White Paper | CAPACITY AND CONDITIONS - STABILITY STORAGE OUTSOURCING CONSIDERATIONS

Gain insights into managing stability and storage conditions to enhance the lifecycle of pharmaceutical products.

White Paper | Biophysical Characterisation of Tocilizumab

Discover key advancements in the biophysical characterization of Tocilizumab presented at the WCB event.

CCCEx Technical Decision Notice (TC 28-2021)

Stay informed about recent CCCEx technical decisions in China regarding explosion-proof products. Download our free English-translated guide for detailed insights.

Battery Resources – FAQs, Webinars, White Papers and More!

Explore the evolving standards and testing methods for battery technologies to meet increasing global demands.

WHITE PAPER | Stability Studies Across the Drug Product Lifecycle

Learn about the key factors influencing drug product stability and how lifecycle management impacts pharmaceutical quality.

WHITE PAPER | Stability Studies Across the Drug Product Lifecycle

Gain insights into managing drug product stability throughout its lifecycle, ensuring consistent performance and safety.

WHITE PAPER | Stability Studies Across the Drug Product Lifecycle

Understand how stability studies play a crucial role in managing the lifecycle of drug products, from development to post-market.

White Paper: Responsible Sourcing in the Building and Construction Sector

Companies must meet rising demands for ethics, accountability, and regulations on environmental and social issues.

White paper download: Auditing solutions to improve management systems and mitigate risks for logistics and transportation

Gain insights into the evolving logistics industry and explore strategies for managing supply chain challenges and improving efficiency.

Top Ten Reasons Products Fail Compliance Testing & Certification

Intertek tests devices to standards. Surprisingly, over 90% of medical electrical devices fail first tests. Failures lead to market delays, costs, brand damage, and safety risks. This document explores common failures to help manufacturers improve design and manufacturing.

WHITE PAPER | Determination of Particulate Contamination in Pharmaceutical Formulations

Learn about the latest techniques in identifying and minimizing particle contamination in the pharmaceutical industry.

White Paper Download - Nutritional labelling: Complying with EU regulations

Rules on nutrition information and how this is displayed on food packaging are designed to ensure the rights of consumers are protected. These labelling rules enable consumers to have comprehensive information on the content and composition of food products, helping them to make informed choices. But this can be a challenge for manufacturers.

White Paper Download - Development testing of driveline electrification technologies

Learn about the testing challenges facing electric vehicle technologies and how to ensure performance, safety, and durability.

White Paper | Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

Understand the analytical approaches to glycosylation, crucial for the development of biopharmaceutical products.

White Paper | Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics

Dive into advanced glycosylation analysis techniques that support regulatory compliance and product quality in the pharmaceutical industry.

WHITE PAPER | Substance Identity Testing Requirements for UK Reach

Explore identity testing requirements under UK REACH regulations to ensure compliance in chemical manufacturing and distribution.

WHITE PAPER | Nanoparticles under REACH

Discover the regulatory requirements for handling nanoparticles under REACH to ensure safe use and compliance.

WHITE PAPER | Nanoparticles under REACH

Learn how nanoparticles are regulated under REACH and the best practices for chemical safety in industrial applications.

Tackling modern slavery in your organisation and your supply chain

WHITE PAPER | Restriction of primary aromatic amines (PAAs) in food contact materials and testing strategies

Explore the testing strategies to restrict primary aromatic amines in food contact materials, ensuring consumer safety and regulatory compliance.

White Paper: Environmental Product Declaration

The construction industry's focus on sustainability has grown, leading to increased interest in Environmental Product Declarations (EPDs) to assess environmental performance. This white paper explains EPDs, their creation process, and challenges, with expertise from Intertek Assuris' global Sustainability Team.

WHITE PAPER | Processability and Evaluation Programmes for Recycled Plastic Materials

Learn about processability evaluation programs for recycled plastic materials and their importance in the circular economy.

Brexit changes to the European Medical Devices Market

Brexit has had a widespread impact on many industries; the electrical medical device market has been no exception. Download our new overview of key requirements for placing a new medical device on the Great Britain (England, Wales, and Scotland) markets as well as the Northern Ireland market.

White Paper | Pharmaceutical Stability Studies and Outsourcing Solutions

Learn about stability testing protocols and their importance in ensuring the longevity and safety of pharmaceutical products.

White Paper | Pharmaceutical Stability Studies and Outsourcing

Discover how stability studies are essential for maintaining the quality and efficacy of pharmaceuticals throughout their lifecycle.

White Paper | Pharmaceutical Stability Studies and Outsourcing Solutions

Gain insights into the comprehensive stability studies required to support the long-term quality of pharmaceutical products.

FAQ: Safety Requirements for Children’s Clothing Sold in Europe

Under the EU General Product Safety Directive (GPSD 2001/95/EC), only safe products shall be placed on the market in Europe. As a result, many children’s products – including clothes – are required to comply with various safety standards that relate to security of attachments, cords & drawstrings, flammability and chemical safety.