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FROM MOLECULE TO MARKET: ANALYTICAL EXCELLENCE FOR DRUG SUBSTANCE AND DRUG PRODUCT

Overview

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

Executive Overview

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.

Core Analytical Capabilities

Core Analytics

Method Development and Validation

  • Stability-indicating method development and validation (HPLC/UPLC) 

  • Assay, identity, and impurity profiling 

  • Chiral HPLC for enantiomeric purity 

  • GC-FID for residual solvents (USP <467>, 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 

Applications: IND-enabling studies, ANDA filings, lifecycle management

ICH Stability

ICH Stability and Release Testing

  • 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 (ICH-Compliant)

Stability Storage

  • 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)

Material Characterization

  • Thermal analysis: DSC, TGA 

  • Polymorph identification and screening: XRPD 

  • Particle size analysis: Laser diffraction 

  • Elemental impurity profiling: ICP-MS 

Value: Risk reduction during process development, scale-up, and commercialization

Impurity Identification

Impurity Identification and Testing

  • 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)

Extractables and Leachables

  • 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

Nitrosamine Testing

  • Ultra-trace detection using LC-MS/MS and GC-MS (EI/APCI) 

  • Comprehensive risk assessments across the API and drug product lifecycle

  • Mitigation strategy development and regulatory support 

Elemental Impurities (ICH Q3D)

Elemental Impurities

  • Risk-based assessment strategies 

  • Method development and validation per USP <233> 

  • Support for complex matrices and aqueous systems 

Compendial Testing

Compendial Testing

  • USP, EP, JP, NF, FCC testing 

  • Compendial verification and customized method adaptation 

  • Support for regulatory submissions and commercial release 

Reference Standard Management

Reference Standard Management

  • Qualification and characterization of reference standards 

  • Full traceability with COA generation 

  • LIMS-enabled lifecycle management 

HPAPI

HPAPI and Sterile Product Support

  • Safe handling and testing compounds upto OEB 5 

  • High-sensitivity PGI detection 

  • Sterile API and Excipient Testing (Particles, pH, Osmolality, Identity) 

Why SmaBio Labs 

  • IND, NDA, 510(k), BLA and ANDA-focused analytical strategy

  • Expertise across small molecules, peptides, and biologics 

  • Advanced instrumentation and regulatory-aligned methodologies 

  • Collaborative, transparent project execution 

  • Regulatory-ready data packages for global submissions 

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