ANALYTICAL METHOD DEVELOPMENT
Analytical excellence underpins successful development. LMS offers end-to-end analytical method development, validation, and characterization to ensure quality, accuracy, and global regulatory compliance throughout the drug product lifecycle.
OUR CAPABILITIES
Method Development & Validation
- Assay, content uniformity, dissolution profiling
- Impurity & degradant characterization
- Filter suitability & extractable analysis
- Lifecycle management for method optimization
Bioavailability Enhancement Technologies
- Amorphous solid dispersions
- Spray drying
- Nano-milling & Particle engineering
- Cyclo-dextrin inclusion complexes
Solubility & Permeability Assessments
- Physicochemical evaluation
- pH-dependent solubility profiling
- Super-saturation studies
Stability Studies
- Accelerated and long-term studies
- Excipient compatibility
- Degradation pathway mapping
- Shelf-life extrapolation
Specialized Testing Services
- Nitrosamine testing for APIs & final product
- Extractables & Leachables
- Particle size analysis
- Dissolution apparatus Types I–VII
Regulatory Services
- IND/NDA/ANDA-relevant analytical packages
- Validation protocols & summary reports
- Method transfer and site-to-site harmonization
WHY LMS?
- Strong analytical integration ensures predictability
- End-to-end support from API through drug product
- Dedicated teams for validation & regulatory filings
- Scalable processes from lab → pilot → commercial
- Regulatory-ready stability packages
FAQs
Can you transfer methods from client sites?
What stability conditions do you support?
How do you select the right technology?
Can you scale successfully for commercial?
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