Capabilities
Drug Substances, Drug Products, and Raw Materials
Comprehensive method development to support R&D, quality control, and regulated workflows
Advanced Chromatography Techniques
HPLC, UPLC, GC, LC-MS, GC-MS, and Ion Chromatography
How We Help
We support laboratories that are new to an application—or launching a new project or venture—by creating custom workflows that reduce trial-and-error and get methods up and running faster.
✔ Assess end-state objectives and method goals
✔ Review system capabilities and configurations
✔ Provide guidance on sample preparation techniques
✔ Design achievable steps and method parameters
✔ Review data reporting and analytical outputs
✔ Troubleshoot technical issues and challenges
✔ Document methods, results, and key insights
Steps in Our Method Development Process
1
Phase 1: Molecular Intelligence
The Goal: Matching the molecule to the right technology.
What we do: We analyze your analyte’s structure (pKa, hydrophobicity, and functional groups) to select the most effective detection technique and a diverse screening set of high-performance columns.
2
Phase 2: Matrix & Sample Engineering
The Goal: “Garbage in, garbage out” prevention.
What we do: We develop specific dissolution and buffer protocols tailored to your matrix. By optimizing the solvent system, we ensure solubility and limit baseline interference, protecting the longevity of your columns.
3
Phase 3: Precision Column Scouting
The Goal: Achieving separation where others fail.
What we do: We leverage a wide knowledge base of Mixed-Mode Chemistries. By utilizing columns that offer multiple mechanisms of interaction (e.g., Ion-Exchange + Reversed-Phase), we achieve resolutions that traditional C18 columns cannot provide.
4
Phase 4: Stress-Testing & Robustness
The Goal: Methods that work every time, on every lot.
What we do: We don’t just find a peak; we optimize for stability. We verify our methods against multiple media lots to ensure that variability remains below 3%, protecting you against “method drift” during long-term production.
5
Phase 5: Implementation & Transfer
The Goal: Seamless integration into your workflow.
What we do: We finalize the method using certified standards: a turnkey Method Transfer to your internal lab. Every project concludes with a detailed technical report and a feedback loop to ensure the method meets your specific regulatory needs.
Trusted By
20+
Years of hands-on chromatography and analytical expertise
6+
Platforms supported
(HPLC, UPLC, GC, LC-MS, GC-MS, Ion Chromatography)
100%
Customized workflows, no one-size-fits-all methods
“Working with GMI’s Method Development team transformed our approach to analytical testing. Their experts helped us assess our goals, design practical workflows, and troubleshoot challenges we didn’t anticipate. Thanks to their guidance, we accelerated our project timelines and achieved reliable, reproducible results with our small molecule and biologic analyses. The documentation and insights they provided continue to be a valuable resource for our lab.”
