We offer a comprehensive array of analytical testing services and expert scientific consultancy from our GMP/GLP and ISO/IEC 17025 accredited laboratories, to meet the needs of clients across the life sciences sector.

 

What is analytical testing?

Analytical testing within the life sciences industry involves the examination of substances, compounds, or materials to understand their chemical composition and behaviors.

 

Why is analytical testing important?

Analytical testing is required to meet regulatory compliance set by agencies like the FDA (Food and Drug Administration) or EMA (European Medicines Agency). It is a critical process within the product development of medical devices and pharmaceutical products to evaluate and mitigate potential toxicological risks for patients or end-users.

 

The benefits of analytical testing with Element

  • Tailored support: We prioritize your requirements by ensuring unique needs are met through a personalized testing process. We advise on appropriate analytical methodologies that span customized testing methods and research protocols to ensure precise results and problem-solving for your manufacturing challenges.
  • Regulatory compliance: Strict adherence to regulatory standards ensures compliance throughout the testing process. Maintaining the utmost levels of technical and regulatory compliance is our priority.
  • Technical expertise: Our analytical chemistry team is highly skilled, ensuring the highest technical standards and detailed feedback to support your product development and process innovation.
  • GxP compliance: Adherence to current Good Laboratory Practice (GLP) and Good Manufacturing Practices (cGMP), assuring test quality and regulatory standards are met.
  • Comprehensive project management: From R&D, to manufacturing, to validation, our testing services encompass the full lifecycle of antimicrobial, biopharmaceuticals, food, medical devices and pharmaceutical products, providing a one-stop solution for clients.
  • Consultancy and training: You'll have direct access to our technical team for any issues with products, methods, or anything relating to chromatography and analytical chemistry. We have a wide selection of ready-made training courses available as well as the resources to tailor courses to your specific requirements.
  • Seamless transitions: Coordination of analytical testing and efficacy testing ensures a smooth transition between testing phases.
  • Support for product registration: Our testing supports registration for antimicrobial products like disinfectants and sanitizers, a critical aspect for market entry and compliance. 
 

Ensuring product compliance 

Navigating compliance challenges can present difficulties in product and drug development projects. We help pharmaceutical manufacturers screen drug active ingredients, examine packaging materials, the chemical analyses of pharmaceutical containers and stoppers, and the analysis of raw materials used in manufacturing processes. For medical device manufacturers, our analytical testing ensures materials meet stringent standards to minimize the risk of biocompatibility issues.

 

Analytical testing services

We also operate a global network of Environmental Testing laboratories for environmental compliance and management.

 

Why choose Element?

Element is not just any GLP and cGMP analytical chemistry testing company. With deep expertise across the antimicrobial, pharmaceutical, biopharmaceuticals, and food, medical device, and pharmaceutical industries, we offer our clients full product and analytical testing solutions throughout the compliance process.

For more information about our analytical testing services, or to request a quote, contact us today.

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