Accelerating Semaglutide development aligned with FDA and EMA guidelines.
Semaglutide, a long-acting GLP-1 receptor agonist, has become a critical component in the therapeutic landscape for type 2 diabetes, obesity, and cardiometabolic disorders. Lambda-Novum offers integrated early- and late-phase solutions to support Semaglutide development aligned with FDA and EMA guidelines.
Comprehensive Early-Phase Services
Focused on timely delivery, quality outcomes, and regulatory compliance
| Study design |
| Protocol development |
| Safety Management |
| PK sampling |
| Safety laboratory evaluations |
| Bioanalysis |
| PK/PD modeling and statistical analysis aligned with regulatory requirements |
| CSR preparation and report compilation |
Clinical & Bioanalytical Capabilities
| Bioequivalence, PK/PD, and food-effect studies |
| Single- and multiple-dose studies in healthy volunteers |
| Complex study designs, including crossover and steady-state regimens |
| Method development, validation, and study sample analysis |
| Immunogenicity assessments: ADA screening, confirmatory, and neutralizing antibody assays |
Experience with Complex Peptides and Long-Acting Molecules
Supporting regulatory submissions via 505(b)(2), hybrid, and generic pathways.
Late-Phase Expertise in Semaglutide & GLP-1 RA Program
Lambda brings strong operational and scientific capabilities in managing late-phase clinical trials for GLP-1 receptor agonists, including Semaglutide. Our capabilities support global Phase II–IV programs with a focus on efficacy, long-term safety, and real-world evidence generation.
Key Capabilities
| • Feasibility assessment, site selection, and patient recruitment strategies for diabetes, obesity, and cardiometabolic studies |
| • Protocol development and regulatory support aligned with FDA and EMA guidance |
| • Centralized project management with global and regional oversight |
| • Late-phase bioanalytical support: PK/PD, immunogenicity, and biomarker assessments |
| • Data management, biostatistics, and CDISC-compliant data submissions |
| • Risk-based monitoring and pharmacovigilance services |
Indications Supported
| • Type 2 Diabetes Mellitus (T2DM) |
| • Obesity / Chronic Weight Management |
| • Cardiovascular Risk Reduction |
| • NASH / NAFLD (observational research focus) |
Connect with our experts at BD@lambda-cro.com to leverage the extensive end-to-end capabilities of Lambda Therapeutic Research & Novum Pharmaceutical Research Services
