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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
Most partners hear back within one business day.
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+1 (919) 704-5617
Tell us about your molecule, your milestones and your timeline.
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104 TW Alexander Dr, Building 18, Research Triangle Park, NC 27709
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