Element Materials Technology
W: www.element.com
LinkedIn: Element Materials Technology
Twitter: @ElementTesting

Toronto, Canada
2395 Speakman Drive
Mississauga, ON L5K 1B3, Canada
T: +1 905-822-4111
F: +1 905-823-1446
Santa Fe Springs, California
9240 Santa Fe Springs Road
Santa Fe Springs, CA 90670
T: +1 562-329-4390
F: +1 562-948-5850
Wilmington, Delaware
1300 First State Blvd, Suite C
Wilmington, DE 19804
T: +1 302-559-7971
F: +1 302-636-0204

 

Element is your partner of choice. Through our global network of laboratories we offer a broad spectrum of pharmaceutical development and testing services. Our core services include analytical method development; batch release; API and raw material analysis; organic and elemental impurities determination; plastics and polymer testing; analytical testing in support of clinical trials, and stability studies. Element is a leader in providing risk-based extractables and leachables programs.

 


SERVICES

Preclinical

  • Toxicology test design
  • Toxicological evaluation
  • Formulation development
  • Pre-formulation analysis
  • Microbiological testing

Clinical Support (Phase I & II)

  • Formulation development
  • Clinical Batch Manufacturing (small-large compounds, parenteral, topical & ophthalmic dosages); Vials, Pre-Filled
  • Container Closure Compatibility, Evaluation and selection studies
  • Materials Risk Assessments
  • Microbiological and Sterility testing

Analytical Testing

  • Solid-state characterization (polymorphism, XRD, DSC, microscopy)
  • Medical device physical deployment testing (syringe actuation force, implant deployment, mechanical properties of biomaterials, etc.)
  • Medical device 510 K
  • Raw Material Excipient and API testing following USP, NF, & EP
  • Trace Metals Impurities
  • Heavy Metals Testing <232> ICHQ3D
  • Development and validation methods for assays and impurities/degradants
  • Analytical testing to support stability
  • Forced degradation
  • Compendia testing (USP, NF, FCC, EP, BP, JP, ACS, etc.)
  • Identification analysis for active pharmaceutical ingredient
  • Microbiological testing
  • Extractables from container closure systems, SUS, manufacturing bioprocessing equipment, and medical devices
  • Leachables from container closure system into drug product
  • Drug product release testing
  • Complementary analysis of dosage forms
  • Stability indicating assay development, validation
  • Stability storage (ICH)
  • Pharmaceutical packaging compatibility
  • NMR (GMP Compliant) and Q-TOF
  • CMC support documentation for IND, NDA, ANDA
  • Particle sizing and characterization
  • Contaminant Investigation
  • Polymer testing and prototype development