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Small Molecules
Method Development and Validation
ICH Stability and Release Testing
Impurity Identification and Testing
Large Molecules
Integrated
Product Development
and Analytical Services
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 drug-device combination products. Science-driven, regulator-ready, partner-first.
FDA-registered lab*
U.S.-based operations
Successful client audits
*Analytical Lab
QbD-Driven Product Development Pathway for Regulatory Alignment
From pre-formulation to launch, SmaBio Labs develops robust, compliant, patient-focused pharmaceutical solutions designed for successful development and scale-up.
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01
Defining Product and Material Attributes to Guide Formulation and Development Strategies.
Physicochemical Characterization
Drug/Excipient Compatibility
Excipient Selection
Define QTPP and CQAs
Pre-Formulation
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02
Formulation Development
Developing Robust Formulations to Support Product Performance, Quality, and Manufacturability.
Proof-of-Concept Batches
Lead Formulation Selection
Packaging Selection & Studies
Identify Critical Material Attributes (CMAs)
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03
Process Development
Designing Robust Manufacturing Processes to Support Consistent Product Quality and Scale-up.
Define Process Design
Define CPPs
Define Equipment Train
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04
Scale-Up and Stability
Confirming Product Robustness Through Scale-Up and Stability 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 to turn 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
Available capacity and responsive project initiation to help programs move forward without unnecessary delays
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Complex Formulations
Specialized expertise in the design and development of complex drug products and combination systems
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FDA-Registered Analytical Lab
Advanced analytical capabilities designed to support rigorous quality and regulatory requirements
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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 Labs
Get in touch with our team of
expert scientists
Tell us about your program, your milestones, and your timeline.
We will contact you within 1-2 business day.
+1 (919) 704-5617
104 T.W. Alexander Drive, Building 18, Durham, NC 27713, United States
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