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SOLUTIONS

Regulatory Support

Deep knowledge of regulations and GLP-compliant required services tailored for your IND and NDA submission

Integrated Model

Lab services directly support our clinical pharmacology, regulatory, and modeling teams

Experienced Team

Scientists with decades of bioanalytical, ADME, and PK program experience

Flexible and Collaborative

Customizable workflows that scale with your program’s needs

Nonclinical Program Management

With over 30 years of drug discovery experience, we bring deep relationships across the CRO landscape to help manage your program through IND. Whether it’s engaging a toxicologist for study design or coordinating pathology review, we provide cost-effective oversight while streamlining program execution across pharmacology, PK, toxicology, and CMC.

Learn more about how we’ve successfully managed Ophthalmology and Neurology programs from discovery through IND.

Pharmacokinetic (PK) Kits

We create, ship, and manage PK sampling kits for small-scale clinical trials, ensuring smooth coordination between clinical operations and GLP bioanalytical labs. Our kits dovetail with the pharmacokinetic analysis of your clinical study and support sparse sampling strategies in Phase 2 and 3 trials—critical for enabling population PK and other regulatory modeling efforts.

Learn more about how sparse sampling in a Phase 2 or 3 trial can support your population PK goals.

In Vivo PK & Metabolism Studies

We offer robust in vivo pharmacokinetic (PK) and metabolism capabilities including our trademarked First-in-Rat™ and First-in-Mouse™ studies. Our services include dose solution analysis, metabolite profiling, and bioanalytical support for nonclinical PK studies. We run the rodent PK studies in house and have 3rd party vendors for large animal studies.

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