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Nonclinical Solutions for

All phases of development

As your comprehensive nonclinical research laboratory, we offer you insightful services at every phase of development.

Comprehensively answer critical questions early and throughout your drug development journey  

Nonclinical research helps you understand how the drug behaves in biological systems as well as its potential toxicity and effectiveness in treating the target disease or condition. Toxicology, pharmacology, metabolism and bioanalysis all play a critical role at each stage of your drug’s development journey.

Drug discovery

Make go/no-go decisions for candidate selection and optimize your lead candidate.

IND/CTA programs

For investigative new drug (IND) and clinical trial application (CTA) submissions, conduct the required GLP-level battery of studies to gain approval to advance into clinical testing phases.

Late-stage development

For new drug application (NDA) or biologics license application (BLA) submissions, assess the potential chronic, reproductive, carcinogenicity and genotoxicity risks as part of your final submission dossier for market approval.

Find the right path forward by viewing our complimentary drug development map. 

Regardless of where you are and how far you aspire to go in your drug development journey, you can advance your program—comprehensively, economically and with unprecedented continuity with a laboratory testing partner that provides strategic approaches designed around your goals.

Future vision

Drug discovery

At the earliest stage of bench research, there are thousands of potential possibilities. This is when you need quick data to make smart go/no-go decisions. With our extensive experience, fast starts and rapid data delivery, you can expeditiously discover the best candidate(s) to move forward.

IND/CTA programs

When your top candidate is identified, you’re ready to complete your IND/CTA program to transition your asset from bench to clinic. From our core battery of safety testing to specialized routes, models and technologies, you’ll find a comprehensive portfolio of solutions to complete your IND/CTA data package with synchronized precision. 

  • Experienced team conducting thousands of studies and more than 130 integrated IND/CTA programs per year
  • Comprehensive suite of GLP services: toxicology, pharmacology, metabolism and bioanalysis
  • All routes of administration—including specialized routes in inhalation, infusion, intrathecal and ocular
  • Specialized study models: large and small animal, cell and gene therapies, in silico or ex silico (i.e., organ-on-a-chip technology)
  • Digital data and visualization—from SEND datasets with automated delivery to digital pathology for peer review and high-volume conversion for archival scanning
Future vision
Future vision

Late-stage nonclinical

Once your drug candidate has advanced into the clinic, late-stage nonclinical studies should be planned and initiated so final data reports coincide with your NDA/BLA submission timelines. This is when study design, advanced animal welfare systems, regulatory guidance and a team well versed in long-term, complex studies will have the most impact on success.

  • Comprehensive late-stage portfolio: chronic, reproductive, juvenile, carcinogenicity, radiolabeled ADME, impurities qualification, environmental risk assessment
  • Global centers of excellence designed for long-term studies: EU housing, welfare AI monitoring and a history of consistent on-time delivery
  • Deep experience in regulatory strategy and guidance for late-stage development and registration
  • Nonclinical regulatory expertise to develop rationale for nonclinical waivers or overcome unexpected challenges that arise during your drug development pathway

Program integration

Save time and gain efficiency with a programmatic approach to drug development. Gain new insights with a prospective planning view that will advance you through the long and complex scientific and regulatory process to maximize the value of your asset.

  • Dedicated team of scientific, regulatory and certified program management advisors
  • Prospective plan to manage and communicate milestones, risk and budgets to stakeholders
  • Integrated insights across your program for smarter decision-making

Asset acquisition and exit

When your business goal is to exit, invest or partner on your asset, you can kick-start strategic conversations with the help of MarketPlace.

  • Expand your network by accessing our complimentary innovative platform that connects asset providers with asset seekers
  • Reach partnering goals faster by accelerating strategic conversations
  • Maximize the value of your partnering efforts; real connections are made every month

Ready to discover the one? Choose our suite of standard and custom discovery biology testing solutions spanning hit validation to candidate selection.