Preclinical Safety Testing for Pharmaceuticals
Bringing a new drug to market successfully is a complex, time-consuming, and expensive process. The Investigational New Drug (IND) and New Drug Application (NDA) regulatory process, along with its international counterparts, requires pharmacology and toxicology studies to be performed before the drug is approved for clinical trials. A systematic approach is required to navigate these challenging pathways successfully. With a solid testing protocol and qualified results, drug developers can bring approved pharmaceutical products to market successfully, recognizing the investment of talent and resources, and supporting the health of patients worldwide.
It is important to partner with the right laboratory who will guide you from preclinical testing, through clinical trials, and ultimately to market. Preclinical pharmaceutical testing helps ensure that your product will pass regulatory approval easily, maximizing your investment and paving the way to successful commercialization.
A Practical Approach to Preclinical Development
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 pharmaceuticals through the approval process to get them to market quickly.
With over 40 years of 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 Pharmaceutical Testing Methods
Toxikon is committed to staying at the forefront of preclinical pharmaceutical 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 drug 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 pharmaceutical developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.
State-of-the-Art Pharmaceutical Testing Facilities
Whether it’s active ingredients, new chemical entities, or final formulation, Toxikon has the staff, methodology, and facilities to ensure best-in-class pharmaceutical 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 system
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 Pharmaceutical Testing
Toxikon is a trusted partner for life science companies, providing the qualified, 3rd-party confidence that drug 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.