From Molecule to Market: Analytical Excellence for Drug Substance and Drug Product
Providing the data, insight, and scientific expertise needed to support IND, NDA, 510(k), BLA, ANDA, and Commercial Programs Across Small Molecules, Peptides, and Biologics
Analytical science plays a critical role in every successful development program. From API characterization through finished product testing, SmaBio Labs delivers the expertise, data, and insights needed to support informed decisions across the product lifecycle. Our team partners with pharmaceutical, biotechnology, and medical device innovators to solve complex analytical challenges, accelerate development timelines, and ensure quality from concept to commercialization.
Supports
- IND
- NDA
- 510(k)
- BLA
- ANDA
- Commercial
Capabilities
Core Analytical Capabilities
Method Development and Validation
ICH Q3C · ICH Q3D · OEB 5
- Stability-indicating method development and validation (HPLC/UPLC)
- Assay, identity, and impurity profiling
- Chiral HPLC for enantiomeric purity
- GC-FID for residual solvents (USP, ICH Q3C)
- LC-MS / GC-MS for PGIs, PMIs, and trace impurities
- High-resolution LC-MS (Q-TOF) for impurity identification
- ICP-MS for elemental impurities (ICH Q3D)
- NMR and qNMR for structural confirmation and potency
- Cleaning validation and counter-ion analysis
- Particle size and dissolution method development
- Safe handling and testing HPAPI (up to OEB 5 compounds)
- High-sensitivity PGI detection
- Sterile API and excipient testing
ICH Stability and Release Testing
ICH Q1 · FDA
- API and drug product release testing
- ICH-compliant stability studies (long-term, intermediate, accelerated)
- Method verification, transfer, and validation
- Comparative and trend analysis
- Regulatory-aligned reporting for FDA and global submissions
Stability Storage Conditions (ICH-Compliant)
- Controlled conditions: 25°C/60% RH, 40°C/75% RH, 30°C/65% RH, 2–8°C
- Frozen and ultra-low storage: −20°C, −30°C, −80°C (biologics)
- Stability programs for small molecules, peptides, biologics, and medical devices
- Full compliance with FDA and ICH guidelines
Material Characterization (Drug Substance)
DSC · TGA · XRPD · ICP-MS
- Thermal analysis: DSC, TGA
- Polymorph identification and screening: XRPD
- Particle size analysis: Laser diffraction
- Elemental impurity profiling: ICP-MS
Impurity Identification and Testing
LC-MS · NMR · Prep HPLC
- Isolation and characterization of organic and inorganic impurities
- Preparative and semi-preparative HPLC
- Advanced LC-MS and NMR techniques
- Support for regulatory investigations and root-cause analysis
Extractables and Leachables (E&L)
NDA · 510(k) · ANDA
- Study design aligned with evolving regulatory expectations
- Container-closure and medical device assessments
- LC-MS/MS, GC-MS, Q-TOF, and ICP-MS platforms
- NDA, 510 (k) and ANDA-ready documentation
Nitrosamine Testing
LC-MS/MS · GC-MS (EI/APCI)
- Ultra-trace detection using LC-MS/MS and GC-MS (EI/APCI)
- Comprehensive risk assessments across API and drug product lifecycle
- Mitigation strategy development and regulatory support
Elemental Impurities (ICH Q3D)
ICH Q3D · USP <233>
- Risk-based assessment strategies
- Method development and validation per USP <233>
- Support for complex matrices and aqueous systems
Compendial Testing
USP · EP · JP · NF · FCC
- USP, EP, JP, NF, FCC testing
- Compendial verification and customized method adaptation
- Support for regulatory submissions and commercial release
Reference Standard Management
COA · LIMS
- Qualification and characterization of reference standards
- Full traceability with COA generation
- LIMS-enabled lifecycle management
Quality · Compliance
Ensure quality from concept to commercialization.
- FDA-registered lab*
- ICH-compliant stability studies
- HPAPI up to OEB 5
- Validation per USP <233>
- Full traceability with COA generation
- Regulatory-aligned reporting
*Analytical Lab