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Integrated
Product Development
for
Complex Drug
Products
&
Combination
Systems.
SmaBio Labs partners with pharmaceutical and biotech teams to design, optimize and scale formulations — from ophthalmics and long-acting injectables to microneedles, transdermals and drug-device combination products. Science-driven, regulator-ready, partner-first.
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FDA-registered lab*
US-based operations
COMPLETED SUCCESSFUL CLIENT AUDITS
Advancing Complex Therapeutics
Technical
Excellence
at Every Stage.
Dosage Forms
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
Transdermal
Drugs Delivery
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QbD Driven Product Development Pathway for Regulatory Alignment
From pre-formulation to launch, SmaBio Labs delivers safe, compliant, effective, and patient-centric pharmaceutical solutions.
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01
Understanding Critical Material Attributes to Guide Formulation and Development Strategies
Physicochemical Characterization
Drug/Excipient Compatibility
Excipient Selection
Define QTTPs and CQAs
Discuss your program
Pre-Formulation
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02
Formulation Development
Developing Robust Formulations to Support Safety, Efficiency, Quality and Manufacturability.
Proof-of Concept Batches
Lead Formulation Selection
Packaging Selection & Studies
Identify CMA
Discuss your program
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03
Process Development
Designing Robust Manufacturing Processes to Support Consistent Product Quality and Scale-up
Identify Process Design
Define CPPs
Define Equipment Train
Discuss your program
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04
Scale Up and Stability
Confirming Product Robustness through Scale-Up and Stability Evaluation Studies
Define Control Strategies
Stability Study Design and Execution
Shelf Life and Storage Assessment
Discuss your program
Why
Smabio Labs
A skilled team and state-of-the-art facilities in Research Triangle Park, NC designed toturn scientific potential into meaningful progress.
Section2
QBD DRIVEN PRODUCT Development Pathway
Pre-Formulation & Compatability
Proof-of-Concept Batches
Lead Identification & Optimization
Process Optimization & Scale-Up
Stability Studies
CTM Manufacturing
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