Table of Content
Comprehensive Analytical Services
Supporting IND, ANDA, and Commercial Programs
Executive Overview
SmaBio Labs delivers end-to-end, cGMP-compliant analytical services designed to support pharmaceutical development from early research through commercialization. Our expertise spans small molecules, peptides, biologics, and complex APIs, with a strong focus on regulatory readiness for IND and ANDA submissions. By combining advanced instrumentation, scientific depth, and regulatory insight, we enable sponsors to accelerate development timelines while maintaining the highest standards of data integrity and compliance.
Core Analytical Capabilities
Method Development and Validation
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Stability-indicating method development and validation (HPLC/UPLC)
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Assay, identity, and impurity profiling
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Chiral HPLC for enantiomeric purity
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GC-FID for residual solvents (USP <467>, ICH Q3C)
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LC-MS / GC-MS for PGIs, PMIs, and trace impurities
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High-resolution LC-MS (Q-TOF) for impurity identification
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ICP-MS for elemental impurities (ICH Q3D)
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NMR and qNMR for structural confirmation and potency
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Cleaning validation and counter-ion analysis
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Particle size and dissolution method development
Applications: IND-enabling studies, ANDA filings, lifecycle management
ICH Stability and Release Testing
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API and drug product release testing
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ICH-compliant stability studies (long-term, intermediate, accelerated)
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Method verification, transfer, and validation
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Comparative and trend analysis
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Regulatory-aligned reporting for FDA and global submissions
Stability Storage (ICH-Compliant)
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Controlled conditions: 25°C/60% RH, 30°C/65% RH, 2–8°C
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Frozen and ultra-low storage: −20°C, −30°C, −80°C (biologics)
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Stability programs for small molecules, peptides, biologics, and medical devices
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Full compliance with FDA and ICH guidelines
Material Characterization (Drug Substance)
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Thermal analysis: DSC, TGA
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Polymorph identification and screening: XRPD
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Particle size analysis: Laser diffraction
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Elemental impurity profiling: ICP-MS
Value: Value: Risk reduction during process development, scale-up, and commercialization
Impurity Identification and Testing
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Isolation and characterization of organic and inorganic impurities
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Preparative and semi-preparative HPLC
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Advanced LC-MS and NMR techniques
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Support for regulatory investigations and root-cause analysis
Extractables and Leachables (E&L)
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Study design aligned with evolving regulatory expectations
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Container-closure and medical device assessments
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LC-MS/MS, GC-MS, Q-TOF, and ICP-MS platforms
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IND and ANDA-ready documentation
Nitrosamine Testing
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Ultra-trace detection using LC-MS/MS and GC-MS (EI/APCI)
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Comprehensive risk assessments across API and drug product lifecycle
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Mitigation strategy development and regulatory support
Elemental Impurities (ICH Q3D)
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Risk-based assessment strategies
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Method development and validation per USP <233>
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Support for complex matrices and aqueous systems
Compendial Testing
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USP, EP, JP, NF, FCC testing
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Compendial verification and customized method adaptation
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Support for regulatory submissions and commercial release
Reference Standard Management
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Qualification and characterization of reference standards
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Full traceability with COA generation
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LIMS-enabled lifecycle management
Environmental Monitoring and Cleaning Validation
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cGMP cleanroom monitoring programs
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Viable and non-viable particulate testing
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Cleaning validation (specific and non-specific methods)
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Microbial disinfectant validation
HPAPI and Sterile Product Support
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Safe handling and testing up to OEB 5 compounds
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High-sensitivity PGI detection
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Sterile API and excipient testing (particles, pH, osmolality, identity)