Advancing your Discoveries into Patient Recoveries
Toxikon provides the qualified, 3rd-party confidence that medical products will perform as expected with minimal risk of adverse effects.
We are proud to play a vital and singular role in the chain of events that move innovative therapies from concept, through research and development, into trials and approvals, through production and commercialization, and finally delivery to the provider and patient. We care about your products – and the life-changing outcomes they can offer – as much as you do.
Qualified and Certified to Deliver Exceptional Biotech Product Testing
With over 40 years of broad and deep experience in navigating the dynamic regulatory landscape, we have the expertise and technical skill to supply you with the results you need to gain approval for your products, demonstrating safety and efficacy.
Toxikon is 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 and other worldwide regulatory agencies to complete submissions and, when necessary, defend challenges.
Staff and Facilities to Meet the Needs of Startup Ventures to Established Companies
Toxikon employs hundreds of scientists, research associates, quality assurance staff, and back-office support, providing a one-stop center of excellence to support product development and testing requirements. All of our testing programs are conducted by us, in our own facilities.
For projects of all types, for companies of all sizes, we can create a testing program that meets your requirements, delivering reliable results on-time and on-budget.
Thought Leadership in Life Science Product Testing
As the both the variety of and complexity of medical devices increases, Toxikon is committed to staying at the forefront of medical device testing by continually evaluating our study methods and research techniques.
Our distinguished scientific staff not only fully understand medical device and pharmaceutical product 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 testing programs have access to the most current and effective methods available, executed under the supervision of industry-leading professionals. Our scientific leadership understands the approval challenges that product developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.
Toxikon: What’s in a Name?
The word toxikon is as old as Greek civilization – it means “a poison in which arrows are dipped.” The tales of Heracles and Odysseus feature the heroes’ poison arrows being critical to their success in battle.
The Greek term toxikon became the Latin word toxicum, which became the French word toxique; it was combined with the Greek logia, for “the study of” to form toxicologie, or toxicology – the study of the nature, effects, and detection of poisons, and the treatment of poisoning.
Today, the study of toxicology, toxicological testing, and assessing the toxicological risk of medical devices, pharmaceuticals, and other biotechnologies offers product developers, prescribers, and patients confidence that these life-altering therapies will work as intended with minimal adverse effects.
The choice of Toxikon’s moniker is as deliberate as our mission: to provide sound science related to the safety, dosing, and efficacy of medical products with the precision and speed of a heroic archer —from pre-market safety through post-market surveillance.
A Strong Foundation in Massachusetts’ Life Science Community
Toxikon was born from the heart of the northeast’s life science sector, the scientific hub of greater Cambridge and Boston, Massachusetts.
Toxikon was founded as Cambridge Diagnostics in 1977 by Dr. Laxman Desai, president and chief executive officer. Cambridge Diagnostics was reincorporated as Toxikon in 1982. Before establishing Toxikon, Dr. Desai managed oncology drug research programs at the Dana-Farber Cancer Institute in Boston. It was through his expertise and experiences there that Dr. Desai saw the opportunity for a high-quality GLP toxicology testing laboratory to serve the needs of life science companies in New England and beyond. Since 1995, Toxikon has operated a 125,000 ft2 campus in Bedford, MA, featuring state-of-the art analytical chemistry laboratories, large animal model facilities, and a comprehensive suite of bioanalytical support services.
Toxikon’s Commitment to Excellence
- To conduct the highest level of quality testing services in the industry
- To provide prompt and courteous services, delivered by a knowledgeable and highly-trained staff
- To be sensitive to special project needs and provide a detailed scope of services to be performed for every study
- To deliver studies to sponsor satisfaction, in a timely and efficient manner
- To feature new services that represent current regulations, following best methods and practices, using current technology
- To respond in a rapid, sensitive, and constructive manner to requests that will enhance your outsourcing experience
- To provide you with an experience that will encourage a continued partnership with Toxikon