Pharmaceutical Development
DMPK and Bioanalytical Solutions (GLP) Method Development & Validation In-vitro DMPK Services In-vivo DMPK Services Bioanalytical Testing
Radiolabeling & Synthesis Solutions non-GMP Services CGMP Services Phase 0 Development Support
CMC & QC Solutions (CGMP) Method Development & Validation Extractables/Leachables Studies Trace Analysis & Structural Chemistry Stability Programs and Release Testing
Environmental Assessments
Regulatory Consulting
Seamless Project Management through Strategic Partnerships
Bioanalysis
FDA Guidance Bioanalytical Method Validation, May 2001
Recommendations for the Bioanalytical method Validation of Ligand Building Assays to support Pharmacokinetic Assessments of Macromolecules, Nov. 2003
Workshop/conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays, Feb 2007
Key Elements of Bioanalytical Method Validation for Small Molecules, 2007
Biomarkers/Translational Medicine
Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement, July 2006
FDA Guidance on Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, April 2008
DMPK
The Conduct of In Vitro and In Vivo Drug-Drug Interaction Studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) Perspective, July 2003
FDA Guidance Draft Drug Interaction Studies, Sept. 2006
FDA Guidance for Industry: Safety Testing of Drug Metabolites, Feb. 2008
ADME studies in animals and humans: Experimental design, metabolite profiling and identification, and data presentation, 2008
Human Radiolabeled Mass Balance Studies: Objectives, Utilities and Limitations, 2009
Early Clinical Research
FDA Guidance For Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, Oct. 2005
GMP
Guidance for Industry CGMP for Phase 1 Investigational Drugs, July 2008