We support the full range of human and animal ADME, bioanalytical and analytical studies with cGMP as well as research-grade and GLP-certified materials–including APIs, reference materials, intermediates and other standards used for impurity and metabolite identification. Our broad capabilities complement in-house drug metabolism, impurity ID and environmental assessment expertise under GLP certification, and expert Program Managers streamline communication through the duration of your development program. Let us show you how to expedite the path to your next development milestone using expertly radiolabeled compounds.
Few contract research laboratories maintain the rigorous cGMP-compliant environment required to produce certified radiolabeled APIs suitable for human clinical trials. EAG maintains four Class 10,000 cGMP Synthesis suites, a dedicated Quality Assurance staff and a group of analytical chemists with years of experience supporting labeled isotope studies. This unique capability complements in-house drug metabolism and impurity ID expertise and streamlines project management.
GMP Radiolabeling Clinical Support
- Human ADME/Mass Balance under cGMP
- GMP API suitable for early clinical trials, including Phase 0 microdosing studies
- Lead optimization
- Metabolite identification – Metabolites in Safety Testing (MIST)
- Radiolabeled (14C and 3H) GMP API for early clinical trials
- Analytical support dedicated to synthesis activities
- Method development and early phase validation
- Certificate of analysis generation
EAG possesses deep experience with all types of chemistries: Lithiation, Grignard, epoxidation, nitration, metal catalysis–as well as chiral separation and asymmetric synthesis and all types of compounds, including carbohydrates, amino acids, peptides and steroids.