Accelerating Drug Development Through Integrated Discovery and Process Chemistry
Advancing drug candidates through innovative chemistry, efficient process development, and scalable manufacturing pathways.
Supports
- IND
- ANDA
- NDA
- 505(b)(2)
- Type II · III DMF
Capabilities
Integrated Discovery & Process Chemistry
SmaBio Labs partners with innovators to accelerate drug development through integrated discovery and process chemistry expertise. From lead optimization and route design to process development and scale-up, we deliver robust, scalable chemistry solutions that help transform promising molecules into development-ready drug substances.
Early-Stage Scientific Support
Accelerating development readiness through screening, characterization, and lead optimization.
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Screening & Assay Development
- Target-based and phenotypic screening assay design
- Assay development, optimization, and validation
- Primary and secondary screening to ensure data robustness and reproducibility
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Hit-to-Lead Characterization
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Lead Optimization
Building a Strong Foundation for IND-Enabling Studies
mg–g Scale API and Intermediate Production
Scale · mg–g
- 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
CQAs · Phase-appropriate
- 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
- Phase-appropriate methods to measure CQAs
- Methods optimized for specificity, sensitivity, accuracy, and robustness
- Enables release testing, impurity identification, and regulatory submissions
Scalable, Phase-Appropriate cGMP Capabilities
kg-Scale API Manufacturing
cGMP · Phase I–III
- cGMP-compliant API production to support CTM manufacturing for Phase I–III
- High purity and batch-to-batch consistency
- Bridging laboratory processes to clinical supply
- Seamless technology transfer and scale-up risk mitigation
- cGMP controls aligned with global regulatory expectations
- Tailored analytical validation strategies by clinical phase
- Early-phase focus on specificity, accuracy, and reproducibility
- Full ICH-compliant validation for late-stage programs
- Shelf-life determination and storage condition verification
Compliance · Regulatory
DMF Filing & Regulatory Support
End-to-End Drug Master File Support for Global Regulatory Submissions
- 01 · DMF
Authoring, and filing of US FDA Type II and Type III DMFs
- 02 · QbD
QbD-aligned process descriptions, including CQAs, CPPs, and control strategies
- 03 · Methods
Analytical method summaries and phase-appropriate validation support
- 04 · IND · ANDA · NDA · 505(b)(2)
Cross-reference support for IND, ANDA, NDA, and 505(b)(2) submissions
- 05 · CMC
Complete CMC documentation covering manufacturing process, controls, specifications, and batch data
- 06 · ICH Q3A / Q3B
Impurity profiling, qualification, and justification per ICH Q3A/Q3B
- 07 · ICH Q1
Stability study design, data generation, and reporting per ICH Q1
- 08 · FDA
Regulatory correspondence support, including FDA information requests and deficiencies
- Batch-to-batch consistency
- Seamless technology transfer
- cGMP controls
- Full ICH-compliant validation