Element offers Rapid Response services on bespoke investigatory analytical testing of pharmaceutical products. Benefit from a flexible approach, quick turnaround times, and precise results to ensure compliance and efficient resolutions.

 

What are Rapid Response services? 

Element’s industry-leading laboratories, equipped with the latest technology, specialize in comprehensive analytical method development and validation. Our mass spectrometry expertise and extensive problem-solving capability cover all aspects of pharmaceutical and consumer healthcare product testing including:

  • Active pharmaceutical ingredients (API) & final drug products
  • Delivery devices & packaging
  • Biopharmaceutical single use systems (SUS)

Fast turnaround times

We are aware that pharmaceutical manufacturers often face urgent deadlines for testing and analysis that cause delays in product development or regulatory compliance issues. Our Rapid Response team collaborate closely with you to cater to time-sensitive requirements, ensuring quick turnaround times to meet your urgent needs.

 

Complex testing for your analytical needs

Analyzing pharmaceutical and healthcare products is a complex process involving meticulous study design to identify impurities that require specialist evaluation. Our analytical laboratories specialize in comprehensive method development and validation, covering a wide range of analytical needs from impurity characterization to investigational problem-solving. Our Rapid Response solutions include investigations relating to:

  • APIs
  • Production process related impurities
  • Degradation products
  • Residual solvents USP<467>
  • Extractables and leachables
  • Extrinsic contamination
  • Elemental impurities - ICH Q3D

Identifying and solving your problems

Do you ever encounter difficulties in identifying impurities, product deformulation, or understanding the root causes of issues? Our investigational and problem-solving capabilities assist you in resolving complex analytical challenges efficiently. They include:

  • Extraction feasibility / solvent compatibility
  • Peak identification
  • Structural elucidation
  • Forced degradation
  • Product deformulation
  • Root cause analysis
Rapid Response Complaince

Meet regulatory compliance

Complying with regulatory standards for pharmaceutical products can be challenging and time-consuming.

Our services help you validate methods adhering to regulatory requirements and ensure compliance with industry standards set by agencies like the FDA (Food and Drug Administration) or EMA (European Medicines Agency).

Advanced instrumentation for accurate results

Access to advanced instrumentation and expert knowledge may be limited, hindering comprehensive analysis. Element boasts cutting-edge instrumentation and expertise across various analytical techniques, ensuring precise and accurate results every time. Our instrumentation includes:

  • Waters Xevo QTOF-MS
  • Agilent LC-MS/MS
  • Agilent GC-MS (headspace & direct injection)
  • Agilent ICP-MS

Achieve precise, timely, and reliable analysis of your pharmaceutical products with Element's Rapid Response services. 

For quick turnaround times, precise results and efficient compliance resolutions, contact us today and streamline your analytical needs.

 

Analytical Evaluation Threshold

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