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Labcorp Message (as of July 21, 4:00 p.m. ET)

  • All Labcorp core systems impacted by the CrowdStrike issues are currently back online.
  • Some of our patient service centers and in-office labs may be experiencing technical issues with retrieving orders.
  • We are working hard to resolve this issue.
  • If you have a copy of your order, this will help expedite the process.
  • We appreciate your patience as we work to restore business operations.

Regulatory 

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.

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.

  • 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

Giving you regulatory direction

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.

Non-GLP

  • Employed for exploratory work
  • Uses assays of high scientific quality and rigor to deliver on endpoints that do not need GLP validation
  • Discovery-phase work, allowing you to cast a wide net

GLP

  • Employed for IND-enabling work
  • Uses validated assays to deliver on specific endpoints relevant to IND filing
  • Assays may be pre-validated, or developed to meet validated status to meet your specific needs
  • Strongest level of safety

Characterizing your molecule to de-risk your future

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.

Validating assays that meet regulatory standards

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.

  • Access a range of assays which meet (and in many cases exceed) regulatory standards in terms of accuracy, precision, parallelism, LLOQ, LLOD, inter-instrument, and so many more
  • To meet GLP standards, we also offer a range of pre-validated assays, or can validate assays specific to your molecule as needed
     

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