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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

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.

Early-Stage Scientific Support

Accelerating development readiness through screening, characterization, and lead optimization.

01

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 , 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

Material Characterization

01

DSC & TGA

Thermal analysis: DSC, TGA 

02

XRPD

Polymorph identification and screening: XRPD 

03

Laser Diffraction

Particle size analysis: Laser diffraction 

04

ICP-MS Profiling

Elemental impurity profiling: ICP-MS 

Building a Strong Foundation

for IND-Enabling Studies

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 (E&L)

  • 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 

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Elemental Impurities , Reference Standard Management and Compendial Testing

04

Testing & Management

Elemental Impurities (ICH Q3D)

Compendial Testing

  • Risk-based assessment strategies 

  • Method development and validation per USP <233> 

  • Support for complex matrices and aqueous systems 

  • USP, EP, JP, NF, FCC testing 

  • Compendial verification and customized method adaptation 

  • Support for regulatory submissions and commercial release 

Reference Standard Management

  • Qualification and characterization of reference standards 

  • Full traceability with COA generation 

  • LIMS-enabled lifecycle management 

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Specialized Support

HPAPI and Sterile Product Support

Impurity Identification

OEB 5 Handling

  • Safe handling and testing compounds upto OEB 5 

High-sensitivity PGI detection 

High-sensitivity PGI detection 

  • High-sensitivity PGI detection 

Sterile API

Sterile API

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

Built for Accuracy. Trusted for Compliance.

01

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

02

  • Expertise across small molecules, peptides, and biologics 

03

  • Advanced instrumentation and regulatory-aligned methodologies 

04

  • Collaborative, transparent project execution 

05

  • Regulatory-ready data packages for global submissions 

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