Customized Testing Programs

Customized testing programs for medical product safety and efficacy

With the proliferation of advanced medical devices, drug delivery systems, reusable medical devices, and combination products that include devices with pharmaceuticals or biologics, we offer a multidisciplinary approach to help you develop a customized testing methodology that mitigates risk while proving safety and efficacy.

It is important to partner with the right laboratory who will guide you from preclinical testing, through clinical trials, and ultimately to market. Custom preclinical testing helps ensure that your product will pass regulatory approval easily: reducing your time-to-market, maximizing your investment, and paving the way to successful commercialization.

With a strong foundation in toxicology and biocompatibility, our customized testing programs have included:

  • IND / NDA enabling studies
  • NCE characterization
  • ocular device and drug product development
  • proof of concept studies
  • surgical efficacy studies
  • comprehensive biocompatibility analysis
  • sterilization support
  • reusable medical device cleaning validation
  • combination product evaluations
  • synthesis and formulation studies

With our breadth and depth of knowledge and experience in all facets of biocompatibility, analytical chemistry, and microbiology, Toxikon is prepared to design custom testing programs that will efficiently and effectively position your medical products for regulatory clearance.

 

Comprehensive Testing from Concept to Final Product

From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your life science products through the approval process to get them to market quickly.

With over 40 years of custom preclinical testing success, Toxikon can be your trusted partner to help you reach your project goals for timely market launch.

 

Superior Quality and Accuracy

Toxikon is a preclinical contract research organization (CRO) accredited to ISO/IEC 17025 – an extensive set of standards confirming our competency as a testing laboratory. Our operations are governed by a rigorous quality management system, ensuring that you can trust the data we deliver in support of your products.

Additionally, we are registered with the United States Food and Drug Administration and the Japan Ministry of Health, Labor, and Welfare for drug and medical testing – and we have demonstrated success with working through these agencies to complete submissions and, when necessary, defend challenges.

 

Thought Leadership in Testing Methods

As the both the variety of and complexity of medical products increase, Toxikon is committed to staying at the forefront of preclinical testing by continually evaluating our study methods and research techniques.

Our distinguished scientific staff not only fully understand testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your device testing programs have access to the most current and effective methods available, executed under the supervision of industry-leading professionals. Our study directors understand the approval challenges that medical device developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.

 

State-of-the-Art Device Testing Facilities

Whether it’s raw materials, components, or finished devices, Toxikon has the staff, methodology, and facilities to ensure best-in-class safety and efficacy testing. With over 125,000 square feet of advanced research space, Toxikon testing facilities include:

  • comprehensive laboratories with top-tier analytical instruments
  • accredited vivarium facilities for large and small species
  • modern surgical suites with state-of-the-art monitoring, imaging and measurement systems

Toxikon’s facilities are registered with the United States Food and Drug Administration and United States Department of Agriculture, and are accredited by American Association for Accreditation of Laboratory Animal Care. We also comply with the NIH’s Public Health Service Policy on Human Care and Use of Laboratory Animals, holding an assurance allowing for the execution of federally-funded studies.

 

Choose Toxikon for Custom Preclinical Testing

Toxikon is a trusted partner for life science companies, providing the qualified, 3rd-party confidence that medical products will perform as expected with minimal risk of adverse effects. Contact us today to discuss your product development needs and learn how we can support your testing requirements.

 

Customized Testing Programs
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For advanced medical devices, drug delivery systems, reusable medical devices, and combination products, Toxikon offers a multidisciplinary approach to preclinical testing that mitigates risk while proving safety and efficacy.