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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.
FDA-registered lab*
US-based operations
COMPLETED SUCCESSFUL CLIENT AUDITS
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
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
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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
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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
Why
Smabio Labs
A skilled team and state-of-the-art facilities in Research Triangle Park, NC designed toturn scientific potential into meaningful progress.
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Chemistry to Clinic
Seamlessly supporting product development from molecule characterization through CTM manufacturing
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Immediate Capacity
Designing Robust Manufacturing Processes to Support Consistent Product Quality and Scale-up
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Complex Formulation
Specialized expertise in the design and development of complex pharmaceutical products and devices
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FDA Registered Analytical Labs
Advanced analytical laboratories built to meet rigorous quality and regulatory expectations
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Successful Client Audits
Consistently earning sponsor confidence through successful audits and compliance excellence
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Expert Analytical Services
Robust analytical solutions that support informed decisions throughout discovery and development programs
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— Contact Us
Start your journey, explore SmaBio
Get in touch with our team of
expert scientists
Tell us about your molecule, your milestones and your timeline.
Most partners hear back within one business day.
+1 (919) 704-5617
104 TW Alexander Dr, Building 18, Research Triangle Park, NC 27709
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