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 Materials Technology is at the forefront of the world’s pharmaceutical and medical device testing services. We deliver trusted contract development and quality assurance to our clients across the globe, providing certainty to physicians and patients. Our Experts specialize in Trace Metals Analysis, Analytical Method Development and Validation, Extractable and Leachable Studies, CMC and Clinical Batch Manufacturing, and more. We surpass our client’s expectations through unrivaled, tailored services, solid partnerships and our proven track record of helping our customers move their products to market faster. That is why, from CMC development through finished product release testing and everything in between, the world’s leading healthcare brands trust Element.


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