Drug Discovery & Process Development

Overview

Concept to Commercialization for the Pharmaceutical Industry

End-to-End Support Guided by Quality by Design (QbD) and Process Analytical Technology (PAT)

Executive Overview

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

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Drug Discovery

Drug Dsicovery

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.

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

A Fully Integrated Development Pathway

Integrated

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.

Keywords: Pharmaceutical drug development services, IND-enabling studies, ANDA development support, small molecule process development, peptide manufacturing, biologics development, QbD, PAT, cGMP API manufacturing, clinical trial material, 505(b)(2) support

DMF Filing & Regulatory Support

End-to-End Drug Master File Support for Global Regulatory Submissions

Authoring, and filing of US FDA Type II and Type III DMFs
Complete CMC documentation covering manufacturing process, controls, specifications, and batch data
QbD-aligned process descriptions, including CQAs, CPPs, and control strategies
Impurity profiling, qualification, and justification per ICH Q3A/Q3B
Analytical method summaries and phase-appropriate validation support
Stability study design, data generation, and reporting per ICH Q1
Cross-reference support for IND, ANDA, NDA, and 505(b)(2) submissions
Regulatory correspondence support, including FDA information requests and deficiencies