Table of Content

Introduction: End-to-End Support Guided by Quality by Design (QbD)

Drug Dsicovery

Drug Discovery & Development

Concept to Commercialization for the Pharmaceutical Industry

SmaBio Labs provides fully integrated drug discovery, process development, analytical, and cGMP manufacturing services supporting IND, ANDA, NDA, and 505(b)(2) programs. Capabilities span small molecules, peptides, and biologics, enabling a seamless transition from early discovery through commercialization and post-market lifecycle management.

Drug Discovery

Early-Stage Scientific Support to Accelerate Development Readiness.

Screening

Target-based and phenotypic screening assay design.
Assay development, optimization, and validation.
Primary and secondary screening to ensure data robustness and reproducibility.

Hit-to-Lead Characterization

Structure–activity relationship (SAR) exploration.
Potency and selectivity evaluation.
Physicochemical property assessment.
Early ADME and developability risk assessment.

Lead Optimization

Iterative medicinal chemistry and biology integration.
Optimization of potency, selectivity, and pharmacokinetics.
Mitigation of safety and developability risks.
Nomination of development-ready lead candidates.

Applications: IND-enabling programs, early pipeline expansion.

Overview

Preclinical Development

Building a Strong Foundation for IND-Enabling Studies.

mg–g Scale API and Intermediate Production

Rapid synthesis to support discovery and early development.
Flexible milligram-to-gram scale manufacturing.
Early feasibility and route evaluation.
Optimization for yield, purity, reproducibility, and scalability.

Small-Scale Batches

Evaluation of synthetic routes and process parameters.
Identification of scale-up and impurity risks.
Support for analytical method development and impurity profiling.
Initial stability assessments.

Analytical Method Development

Phase-appropriate methods to measure critical quality attributes (CQAs).
Methods optimized for specificity, sensitivity, accuracy, and robustness.
Enables release testing, impurity identification, and regulatory submissions.

Clinical Development

Scalable, Phase-Appropriate cGMP Capabilities.

kg-Scale API Manufacturing

cGMP-compliant API production.
High purity and batch-to-batch consistency.
Bridging laboratory processes to clinical supply.
Seamless technology transfer and scale-up risk mitigation.

CTM and Submission Batches

Manufacture of Clinical Trial Material (Phase I–III).
cGMP controls aligned with global regulatory expectations.
Submission batches supporting IND, NDA, and ANDA filings.

Phase-Appropriate Method Validation

Tailored analytical validation strategies by clinical phase.
Early-phase focus on specificity, accuracy, and reproducibility.
Full ICH-compliant validation for late-stage programs.

Regulatory Pathways Supported: IND → NDA / ANDA.

Launch & Commercialization

Reliable Manufacturing and Quality Systems for Market Readiness.

Commercial-Scale API Production

Full cGMP manufacturing for commercial supply.
Robust quality oversight and process control.
Technology transfer and lifecycle management.

Process Validation Batches

Demonstration of process reproducibility at commercial scale.
Control of critical process parameters and CQAs.
Support for regulatory filings and process qualification.

Quality and Regulatory Support

Deviation management and change control.
Batch record review and document governance.
Audit readiness and regulatory inspection support.

Final Method Validation for QC

Full ICH-compliant analytical validation.
Reliable release and stability testing.
Long-term support for commercial quality control.

Post-Launch & Lifecycle Management

Sustaining Long-Term Product Success.

Commercial Product Release Testing

Identity, purity, potency, and safety testing.
Regulatory-compliant data review and batch disposition.

Ongoing Stability Programs

Shelf-life determination and storage condition verification.
Annual product reviews and change control support.

Commercial Manufacturing

Consistent cGMP production with validated processes.
Equipment qualification and comprehensive documentation.

505(b)(2) Pathway Support

Strategic and technical CMC support.
Gap analysis and bridging strategies.
Accelerated development leveraging existing data.

Integrated Pathway

Integrated

A Fully Integrated Development Pathway

From concept to commercialization, SmaBio Labs integrates drug discovery, process chemistry, analytical sciences, regulatory strategy, and cGMP manufacturing to create an efficient, risk-mitigated pathway to market.