Safety Assessment

From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services and regulatory support to comply with worldwide regulatory restrictions for the nonclinical development of pharmaceuticals, medical devices and animal health products as well as chemicals, agrochemicals, and biocides. Our scientific and regulatory staff work with clients to develop and execute individual studies or customized testing programs to ensure that drug safety and efficacy assessments are conducted in the most efficient manner.

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IND-Enabling Studies Toolbox

Planning for your IND-enabling studies requires the right partner to support your program, preparing the proper test articles, and planning your submissions. Make sure you choose a partner that can quickly mitigate any risks, deliver reports quickly, and offer actionable insights to submit your investigational new drug application on time.

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remote audit

Full-Service Audits at Your Fingertips

The COVID-19 pandemic has pushed our industry to think differently about how we work and change the status quo, emphasizing the importance of evolving programs with agility and flexibility. To that end, one process that can absolutely evolve and meet the needs brought on by this new landscape is the QA facility qualification or data audits conducted by sponsors for their contracted or outsourced work.

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Can my Research Continue?

Simply, yes. From virtual consultations and digital resources to fully operational facilities, our team has what you need to move forward.

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