The Reproduction Toxicology unit constitutes one of the core functions of SafePharm Laboratories. With a broad international client base representing the Industrial Chemical, Agrochemical and Pharmaceutical industries, SafePharm provides flexibility of service to support the requirements of our clients.

The recent expansion of the mammalian toxicology facilities has allowed an increased capacity for performance of reproduction toxicology studies, in response to the increased demand for these type of projects.

The type of study designs performed include:

• Single and multigeneration studies in rodents for chemicals and agrochemicals
• Developmental studies in rodents and rabbits for chemicals, agrochemicals and pharmaceuticals
• Fertility, pre- and post-natal studies in rodents to ICH designs

The Reproduction Toxicology unit offers the scientific and technical procedures necessary to fulfil the requirements for regulatory submissions for all types of new chemical entities. Many of these technical procedures reflect the most recent changes to regulatory guidelines world-wide. These procedures include the acquisition of the computer assisted semen analyser in order to perform the techniques recommended in the principle regulatory guidelines for multigeneration studies.

The unit can offer flexibility in study design to accommodate client needs. This is reflected in our design to combine both subchronic and reproduction toxicity assessments into one study. These studies can be modified to suit the requirements for HPV chemical testing. The unit has successfully performed in vivo screening for endocrine disruption to satisfy client in house safety assessment.