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Methods delivered to the highest global regulatory standard with the ability to transfer your assay among our nine global facilities with the help of our dedicated scientific team.
Take advantage of the world’s broadest range of compound knowledge, scientific expertise and efficiency in method feasibility, development, validation and transfer for bioanalysis. Our highly trained technical staff develops robust methods using the latest technologies to deliver consistent performance throughout your large- or small-molecule program.
You have the flexibility to transfer methods among any of our seven global facilities. Our scientists routinely establish and validate more than 1,400 proprietary and nonproprietary bioanalytical methods annually.
From preclinical to late stage clinical, receive end-to-end support for a wide range of study types to move your program forward.
We’ll support your mammalian toxicology studies with TK data to correlate safety and drug blood concentration levels in animal models.
We support your early clinical single or multiple ascending dose through late stage studies with robust methods to establish optimal dosage and dose frequency.
Our team will partner with you to compare pharmaceutical alternatives to evaluate therapeutic equivalents.
We provide an integrated service with our Central Laboratories to help you reduce errors, provide chain-of-custody sample tracking, coordinate sample shipments and integrate your reports for regulatory submissions.
We’ll help you with robust methods and rapid data turnaround time to assess the potential impact of drug-drug interactions. We publish all nonproprietary methods.
You’ll get comprehensive statistical data analysis for TK report integration into regulatory submissions using WinNonLin® and SAS™.
Assess your drug’s immunogenicity profile with our proven three-tiered approach.
When it comes to developing your biologic, our team understands there is no standard path and each compound requires a unique solution. As your partner, we take the time to understand the complexity of your molecule and work with you to develop a solution for your program.
When you partner with our team, you’ll get unmatched experience and expertise. We offer regional and global solutions with access to:
The FDA, EMEA and other regulatory agencies recommend thorough immunogenicity assessment of your drug's immunogenic potential. We bring more than 30 years of experience to the construction and implementation of a three-tiered strategy to assess the immunogenicity of your biologic:
When facing challenges with low volumes you can rely on our highly sensitive assays and LC-MS expertise to deliver unique solutions.
Does your study produce low sample volumes, creating bioanalytical challenges? We understand that capillary microsampling is gaining popularity due to ethical and scientific advantages.
Our experienced team has a demonstrated track record of delivering quality results for high sensitivity assays with low sample volumes. As your partner, we can deliver unique solutions when you’re challenged with low sample volumes.
