Chorley Consulting are an independent toxicology consultancy based in the UK.  We specialise in designing safety assessment programmes for medical devices.  We offer expertise in:

• Biological evaluation of medical devices
• Study management of biocompatibility and E&L studies
• Toxicological risk assessment of E&L substances
• QSAR analysis using Toxtree, Derek Nexus and Sarah Nexus systems

We work with clients ranging from multinational device manufacturers to start-ups and have experience with assessing the biological safety of a wide range of device types.  Our biological evaluation plans and reports have formed part of submissions to notified bodies and authorities as well as supporting clinical trial applications.
Chorley Consulting works to a comprehensive quality management system and are certified to ISO 9001. We employ a team of experienced safety assessors, including a number of UK/European registered toxicologists. This give us the flexibility to support multiple projects and work with clients to achieve the required timelines.
 

A globally respected, ISO/IEC 17025:2017 accredited analytical laboratory based in Manchester, UK, specialising in complex trace analytical chemistry.
Our mission is to deliver innovative and high-quality analytical expertise to strengthen our clients’ ability to improve product safety and reduce harm to patients and consumers. We partner with customers in the pharmaceutical, biopharmaceutical, medical device and consumer sectors to ensure their products are safe and compliant with pertinent regulations.
 
We specialise in  Extractables and leachables testing for the pharmaceutical, biopharmaceutical and medical device companies.
Many of the areas we work in are in a rapidly evolving regulatory environment, Element Manchester - Life Sciences is equipped with the knowledge, expertise and instrumentation to navigate the ever-changing regulations that ensure your products compliant with these regulations.
 
Element Manchester is members of the UK Good laboratory practice (GLP) monitoring programme.

The World’s Leading MedTech CRO Offering Global End-to-End Development Services.
Driven by our regulatory expertise and in-depth therapeutic knowledge, NAMSA has assisted thousands of MedTech Sponsors make a positive impact to healthcare since 1967. Today, our team of global Associates delivers market-leading Contract Research Organization (CRO) services to Clients in all major markets of the world. NAMSA provides unparalleled medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction and commercialization. From concept to post-market, we are proud to fully support Clients through the delivery of exceptional outcomes throughout every stage of the MedTech development continuum.
 

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.
 
The dedicated and highly specialized extractables and leachables (E&L) team in the PPD® Laboratories GMP lab has more than 15 years of experience providing full-program support for all aspects of E&L studies, including overall study design/consulting, container/closure selection as well as manufacturing process qualification and validation. Our E&L team and toxicology experts work with clients to make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies, development of extractable and leachable methods, leachable stability testing, batch extractables testing and USP compendia testing support.

Smithers helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.

Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.

We can assist throughout your medical device product development.

Services include:

• Extractables and leachables studies
• Device physical and functional testing
• Device verification and validation
• Product and packaging durability, integrity and stability testing
• Material selection, property characterisation, life prediction
• Failure analysis