Global regulatory standards and guidelines are constantly evolving. Making sure your molecule is compliant at a preclinical phase is vital to support a successful IND/CTA filing, getting you closer to FIH and beyond.
Approximately 200 unique test articles assessed per year
Assays available as non-GLP “discovery phase” or validated to GLP standards
Supporting programs from in vitro pharmacology through the clinic
At Labcorp Drug Development, we provide you with evidence and data that goes beyond guidance requirements, so you have a better holistic understanding of your molecule. By using regulatory science to build a program specific to your molecule, we can anticipate regulatory hurdles and prepare you for challenges right from the start.
Whatever your needs, we have an extensive and highly experienced regulatory team who can support you.
Our approach to navigating the regulatory landscape is based around performing work of the appropriate quality for your needs. By assessing the weight of evidence needed for your molecule to move forward, we can intelligently employ GLP and non-GLP assays where appropriate. This ensures that not only do you have the data to meet regulatory standards, but also that your program is cost-effective and fit-for-purpose.
At Labcorp Drug Development, we work with you to characterize and formulate cell-based test articles and build an assay strategy specific to your molecule. This not only ensures you are fully characterized to a level acceptable to the regulator, but also helps to de-risk the development of your large or small molecule.
Better cytokine release assays that reflect the pharmacology taking place are becoming more predictive of clinical outcomes. With a clearer understanding of the framework of your molecule and its targets at a preclinical stage, we can de-risk the future of your program.
Over the course of your development program there are a whole range of assays at your disposal. Our team of experts can cut through the confusion and find the right assay to get the data you need.
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Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.
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