Integrated Services
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.
Services
From early-stage discovery through product and process development, analytical services, and commercialization readiness, SmaBio Labs provides integrated scientific support with regulatory precision.
Comprehensive analytical development and validation supporting regulatory submissions, product release, and long-term lifecycle management.
Strategic formulation and CMC development designed to advance APIs into stable dosage forms ready for clinical development.
Integrated discovery and process chemistry designed to deliver scalable, efficient routes from early research through API scale-up.
ICH-compliant stability storage and analytical testing supporting clinical development and global regulatory submissions.
GMP-compliant clinical trial material manufacturing supporting early-phase studies and regulatory submissions.
Flexible synthesis support for API intermediates, reference standards and impurities.
Quality, Process and Compliance
A skilled team and state-of-the-art facilities in Research Triangle Park, NC, designed to turn scientific potential into meaningful progress.
Advanced analytical capabilities designed to support rigorous quality and regulatory requirements
Robust analytical solutions that support informed decisions throughout discovery and development programs
Seamlessly supporting product development from molecule characterization through CTM manufacturing
Available capacity and responsive project initiation to help programs move forward without unnecessary delays
Specialized expertise in the design and development of complex drug products and combination systems
Consistently earning sponsor confidence through successful audits and compliance excellence
Development Pathway
From pre-formulation to launch, SmaBio Labs develops robust, compliant, patient-focused pharmaceutical solutions designed for successful development and scale-up.
Step 01
Defining Product and Material Attributes to Guide Formulation and Development Strategies.
Step 02
Developing Robust Formulations to Support Product Performance, Quality, and Manufacturability.
Step 03
Designing Robust Manufacturing Processes to Support Consistent Product Quality and Scale-up.
Step 04
Confirming Product Robustness Through Scale-Up and Stability Studies.
Dosage Forms
Solutions, suspensions, emulsions, and lyophilized products require precision in sterility, solubility, and stability.
Ophthalmic formulations demand exceptional precision in sterility, stability, drug delivery, and patient comfort.
Topical formulations require the right balance of efficacy, texture, absorption, and skin safety.
Medical device development requires careful consideration of product performance, safety, compatibility, and regulatory requirements.
Transdermal patch development demands precision, from drug selection to skin compatibility.
Testimonials
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Leadership
Meet the quality and scientific leaders guiding SmaBio Labs, with deep expertise across quality assurance, product development, analytical services and manufacturing
About Us →
CEO/Co-Founder
Leading the company's vision, driving growth strategies, and overseeing overall operational excellence to ensure sustainable success.
Associate Vice President, Operations
Managing technical operations, optimizing process workflows, and ensuring seamless execution of technical projects.
Director of Analytical Services
Overseeing analytical operations, ensuring quality control, and leading the development of robust analytical methods.
Site Quality Head Consultant
Pharmaceutical quality leader with 25+ years across pharma, biotech, and CDMO organizations.
Facility
With an experienced team and state-of-the-art facility, we provide responsive, quality-focused development support.
2023
Apex, NC · 2,000 sq. ft.
2024
RTP, NC · 10,000 sq. ft.
Early-Phase GMP Manufacturing
2025
2026
Research Triangle Park, NC
Contact Us
Get in touch with our team of expert scientists
Tell us about your program, your milestones, and your timeline.
