Services and Capabilities Overview
Experience, Expertise and Excellence
Toxikon is a contract research organization (CRO), with ISO/IEC 17025 accreditation, providing biological and analytical services for the pharmaceutical, biotechnology, and medical device sectors. Toxikon’s safety services include toxicology (acute, subchronic, and chronic toxicity, reproductive toxicity, genetic toxicology, and carcinogenicity), pharmacokinetics, toxicokinetics, bioavailability, ADME, chemical characterization, impurities analysis and synthesis, bioanalytical, and microbiology/virology. Toxikon’s certifications and licenses allow it to meet extensive regulatory requirements for data acceptability.
No matter what your program needs are, you can rely on Toxikon to be a flexible partner with the technical, research and development expertise to meet your development goals in a timely manner for market launch. We not only want to provide you with the excellent service, we aim to work closely and collaborate with you so that we understand your needs and develop sound programs that provide a clear direction for your project.
Whether it’s a combination product, an anticancer or antiviral compound, Toxikon has the experience and is a proven life science leader with staff of scientific distinction who can multiple services to the development of medical devices and therapies that will ultimately improve the quality of life.
Why CoLABorate with Toxikon?
With Toxikon you gain a strategic and responsive scientific partner, who not only brings reliability, trust, and flexibility to the table, but also the assurance that data reviews withstand both pre-market and post-market safety assessments and meet your product goals.
Whether you are a pharmaceutical, medical device, or biotech company, collaborating with Toxikon provides you access to a team of experts well versed in a comprehensive range of compound structures, therapeutic targets, as well as medical devices and combination products.
Creating a Path for Development
Toxikon understands that life science companies need solid technical partners throughout product development stages, and as a preclinical CRO with more than 30 years of experience, our accomplished scientists and study directors possess the educational backgrounds and technical know-how to efficiently perform a variety of regulatory and customized studies.
Our concept-to-finished product approach will guide you through efficacy, IND enabling studies, and finished product testing; whether it is a device, drug, or biologic, Toxikon can guide you through any testing paradigm.
Committed to Compliance
Toxikon is committed to excellence in everything that we do. As an accredited firm, we are in full compliance with not only FDA and USDA regulations, but also with international and industry guidelines, whether mandated or voluntary.
Toxikon is also committed to quality; we have dedicated, registered quality assurance and regulatory professionals onsite, who are continuously auditing our quality management systems, protocols, SOPs, subcontractors, and suppliers.
Additionally, Toxikon continues to make significant capital improvements including the installation of fully integrated electronic environmental monitoring systems throughout the Bedford and Leuven campuses. In addition, to complement the existing fully validated biology / toxicology laboratory information management system (LIMS), the company plans has implemented ECM and LIMS to increase data and reporting throughput as well as improve data quality. Validation of this new LIMS is near completion. There are other ongoing automation projects including, Agilent Open Lab, ECM and instrument integration. In fact, recent enhancements and upgrades to lab operations and processes can reduce study reporting timeframes by an estimated 50 to 60 percent.