As materials and technologies advance, the biomedical industry is experiencing a convergence of technology, pharmaceuticals, medical devices and diagnostics for improved treatments and therapies. EAG Laboratories offers biomedical analysis services to evaluate the materials, chemistries, and components in the latest products.
From surface chemistry to physical properties, we have established ourselves as the premier scientific services company with expertise in biomedical products, chemistries and materials, regulatory insight, and a proper sense of urgency to deliver meaningful results with an impact.
EAG’s team of scientists have a passion for developing appropriate scientific studies to provide insight and solutions to the latest technical problems. Our laboratories are equipped with numerous pieces of state-of-the-art instrumentation and equipment to ensure reliable results and minimize the chance for down time.
These tools provide understanding for:
Our customers value the scientific interaction they receive during project scoping and discussion. Please call us at 800-366-3867 or complete the ASK AN EXPERT form to speak with one of our scientists about your biomedical analysis challenges.
Biomedical Analysis: Chemistry and Materials Expertise
Pharmaceuticals, medical devices and diagnostics utilize a complex set of chemistries and materials to ensure efficacy of the product in addition to patient safety. Examples have included development of critical surface chemistries to improve device stability and biocompatibility, drug substance stability on an intradermal delivery system, or diagnostic testing on a chip.
EAG Laboratories has experience in a variety of chemistries and materials including:
Our scientists and engineers have access to a diverse set of analytical instrumentation to serve as an extension to your analytical R&D group including:
- Organic Characterization: FTIR, NMR, GC/MS, LC/MS, GPC, TGA, DSC, TMA, DMA
- Surface Analysis: XPS/ESCA, Auger, TOF-SIMS, SIMS
- Crystallography: PXRD, single crystal XRD
- Microscopy: SEM/EDS, TEM/EDS, STEM, FIB-SEM
- Elemental Analysis: ICP/OES, ICP/MS, GDMS, IGA
Biomedical Analysis Requires Regulatory Insight
We are in an ever-increasing world of regulatory oversight which continues to become involved earlier in the development process. While this can help the regulatory submission process later in the development cycle as well as provide valuable insight during investigations, too much regulatory control can also hinder innovation. The biomedical and pharmaceutical development engineers and scientists are consistently weighing the needs of regulatory and testing that can answer complex scientific questions relating to materials used in products.
Want to learn more about the appropriate regulatory standards for outsourcing analytical project to support medical device development? Read our latest white paper!
EAG Laboratories understands those needs and has built laboratories on a strong foundation of quality as well as developed the technical advising staff to understand the development cycle and what regulations apply. Our large scale comprehensive QC program guarantees standard calibration procedures, validated methods third-party audits.
We carry ISO 17025 Certification at most of our Materials and Engineering Sciences laboratories. We also have supported standards organization such as ISO and ASTM in the development of those standards used in regulatory submissions as well as providing the necessary data to help notified bodies write guidance defining what is needed to have a successful submission. EAG’s technical advising staff also knows when certain regulatory requirements are needed. They can foresee where the regulatory requirements will apply and provide options to the development engineers and scientists to design a more perfect study that could save time and money long term.
Whether you are early in the development process and evaluating new materials/process or need support in the validation/verification process or are gathering the necessary characterization on the materials for your biocompatibility assessment or are evaluating a failure investigation EAG KNOWS HOW and when to apply the appropriate regulatory requirements.
Sense of Urgency
As a premier scientific services provider, we recognize the importance of delivering results and answers to critical questions within a time frame to make an impact. We foster a proper sense of urgency with our scientists and engineers, accomplished by:
- Capital Resource Management: In most cases within EAG, we have multiple pieces of instrumentation for our variety of techniques. This allows us back up instrumentation in the event and instrument is out of service. Additionally, the multiple pieces of equipment increase our overall capacity for throughput thus allowing us to deliver results within a reasonable timeframe.
- Efficient Scientific Services Process: We have developed a proprietary, in-house LIMS system that allows for efficient sample management and throughput in the lab.
- Lab Culture: Our scientists embrace an efficient lab culture and are passionate about delivering results to make a meaningful impact.
Contact EAG’s biomedical analysis experts at 800-366-3867 or complete the ASK AN EXPERT form to speak with one of our scientists about your challenges.