Toxikon Europe - CRO Providing Preclinical Safety Studies for the Life Science Community
CRO Providing Preclinical Safety Studies for the Life Science Community
For more than 30 years, Toxikon has been a leading contract research organisation providing high quality preclinical safety studies to the life science community.
Toxikon operates state of the art facilities in the US as well as Europe, both locations being FDA Registered and ISO 17025 Accredited. As a CRO, the company offers its services in Worldwide Compliance Testing for the Medical/Pharmaceutical and Biotech Industries.
Extractables and leachables studies
Toxikon Europe has a vast expertise in Extractables/leachables (E/L) Testing, and in this field of expertise the laboratory runs the corresponding GMP programs, which are necessary to meet FDA, EMEA and PQRI requirements.
Container / closure testing and physico-chemical, in-vitro and in-vivo biocompatibility testing
Toxikon Europe cooperates with leading container / closure manufacturers and pharmaceutical companies to help these industries to comply with the new requirements of container / closure testing.
In addition to a comprehensive analytical approach, based upon a broad array of analytical techniques to study container / content interactions, Toxikon Europe also provides services in physico-chemical, in-vitro and in-vivo biocompatibility testing, according to European -, US - and Japanese Pharmacopoeias.
Toxicological risk assessment for extractables and leachables studies
In addition, Toxikon can assist in the assessment of the scientific data, obtained in both extractables and leachables studies, via a toxicological risk assessment. These toxicological studies try to assess if the E&L concentration levels, present in the active substance / medicinal product, can be considered as "toxicologically safe".
The extractables and leachables -protocols, developed by Toxikon, are well accepted by all market leading container / closure manufacturers and pharma companies. Customised protocols can be developed for specific applications: disposables, injectables and parenterals, inhalables, ophthalmics.
QP-batch controls, rapid microbiology development and preclinical testing capabilities
The company is knowledgeable of all regulatory pathways and strategies, many of which are negotiated based on scientific data with the regulatory agencies. Toxikon participates in defending product submissions and negotiating strategies for its clients. Its services will continue to change as regulatory testing requirements dictate these changes, and as testing technology and instrumentation improve.
Toxikon Europe is currently expanding its services into the pharmaceutical industry related to QP-batch controls and the development of rapid microbiology techniques.
Besides the extractables and leachables testing, Toxikon as a group offers a wide range of preclinical testing capabilities for the pharmaceutical industry.
Toxikon Europe nv
Romeinsestraat 12
B-3001 Leuven
Belgium
Jos Bollen – director, Europe
Dr Piet Christiaens – scientific director
Tel: +32 16 400484
Fax: +32 16 401304
info@toxikon.be
www.toxikon.be
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