01
Clinical Packaging and Labeling
Blinded/unblinded labels, multi-language booklet, tamper-evident, QR/e-labels for clinical trials.
Integrated Product Development for Complex Drug Products and Combination Systems
Delivering the formulation expertise needed to advance drug products from pre-clinical development through clinical evaluation and regulatory submission.
SmaBio Labs provides product development support for complex and conventional dosage forms, including ophthalmic products, long-acting injectables, drug-device combination products, and standard formulations. Our scientists work as an extension of our partners' teams to design and optimize formulations aligned with defined development objectives. Through a collaborative, science-driven approach, we help partners navigate development challenges and generate the data and understanding needed to advance programs toward clinical success and support efficient regulatory submissions.
Supports
- IND
- NDA
- ANDA
- 505(b)(2)
Development pathway
QbD Driven Product Development Pathway for Regulatory Alignment
Step 01
Pre-Formulation Studies
Defining Product and Material Attributes to Guide Formulation and Development Strategies.
- Physicochemical analysis
- Comprehensive evaluation of physicochemical properties: polymorphism, crystallinity, particle size, solubility across pH, hygroscopicity, bulk/tapped density, flow, and compatibility with excipients.
- Compatibility Studies
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Conducted during pre-formulation to identify and mitigate interactions impacting safety, stability, efficacy, or manufacturability.
Benefits
- Accelerating formulation by eliminating incompatible excipients early
- Enhancing product safety, stability, and shelf life
- Ensuring compliance with regulatory guidelines
- Possible incompatibilities
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- Physical (color change, eutectic formation, phase separation)
- Chemical (hydrolysis, oxidation, reduction, precipitation, decarboxylation, racemization)
- Thermal (interactions caused by heat during processing)
- Common methods
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- Thermal studies (DSC, TGA)
- Spectral (FTIR, X-Ray Diffraction)
- Chromatography (HPLC)
- Rheological (viscosity, flow properties)
Step 02 · QbD Driven Approach
Formulation Development
Developing Robust Formulations to Support Product Performance, Quality, and Manufacturability.
- Proof-of-Concept (PoC) Batches
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- Define QTPP and CQAs
- Success criteria (quality, safety, stability, bioavailability, efficacy)
- Source raw materials by CMAs
- Processing framework via DoE
- Evaluate PoC
- Case studies with scalability protocols
- Prototype batches for regulatory readiness
- Lead Formulation Identification
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- One or two lead formulations meeting QTPP and CQAs
- Integrity
- Quality (drug release, assay, content uniformity, bioavailability)
- Excipient selection and ratio ranges (DoE)
- Stability (long-term and accelerated)
- Packaging (primary and secondary)
- Lead formulation optimization
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- Optimal process parameters, stability risks, packaging/storage controls
- Scalability
- Process (equipment, parameters, simulate scale-up, transferability)
- Risk assessment and stress conditions
- Mitigation across ICH climatic zones
- Stability StudiesICH ZONES I–IVb
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Identifies degradation risks and confirms shelf life. ICH-compliant stability protocols across Zones I–IVb. Includes accelerated (40/75), long-term (25/60) and Intermediate (30/65) and photostability testing.
- 40/75 accelerated
- 25/60 long-term
- 30/65 intermediate
- Photostability
- Packaging Material Selection
- Evaluation of moisture, oxygen, light barriers; migration, leachable, seal integrity, physical strength, compatibility with formulation. Includes accelerated and real-time validation studies.
Step 03
Process Development
Designing Robust Manufacturing Processes to Support Consistent Product Quality and Scale-up.
- Process Identification
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Product Process Liquids Homogenization, sterilization Sterile product Aseptic fill/lyo Transdermal patches Coating, drying and converting Solid orals Blending, granulation, drying, milling, compression, coating CPPs identified and optimized.
- Process Optimization (Lab Scale)
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A systematic DoE- and QbD-based approach is used to refine and control manufacturing processes.
- Map unit operations
- Identify CPPs impacting CQAs
- Define PARs
- Establish boundaries and operating ranges
- Link material attributes, process parameters and CQAs
- Process Scale-Up
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- Pilot and engineering batches
- CPPs and PARs challenged
- Bottlenecks (mixing, heat transfer, hold times, filtration, transfer) assessed and mitigated
- Process validation with in-process controls
Step 04
Preclinical and Clinical Trial Material Manufacturing
GMP-compliant CTM for Phase I–II. Manufactured in classified cleanrooms. Includes analytical validation, warehouse control, and support for IND, NDA, ANDA, 505(b)(2) filings.
- GMP Phase I–II
- IND · NDA · ANDA · 505(b)(2)
Specialized Services
Specialized Services
02
HPAPI Formulation and Potent API handling
Specialized containment, FFU/HEPA, safe handling SOPs, hormones/steroids expertise, and analytical validation.
03
Aliquoting (cGMP)
APIs, excipients, biologics aliquoted under cGMP. Traceable, secure, labeled, and logged for clinical supply.
Dosage forms
Dosage Forms Supported
01
Ophthalmic Formulations
Eye Drops · Ointments · Gels
- Eye sensitivity, sterility, non-irritation
- pH, osmolality, viscosity, particle size
- Preservative effectiveness
- Aseptic formulation, ICH stability
- Solutions, suspensions, ointment and gels
02
Sterile Formulation
Solutions · Suspensions · Emulsions · Lyophilized
- Solutions, suspensions, emulsions, lyophilized products
- Sterility, endotoxin/pH/osmolality control
- Aseptic processing
- Container closure compatibility
- Regulatory support
03
Topical Formulations
Creams · Gels · Ointments
- Efficacy, texture, absorption, skin safety
- Emulsifiers, gelling agents, penetration enhancers
“SmaBio Labs delivers stable, patient-friendly formulations from concept to commercial readiness.”
04
Transdermal drug delivery
Matrix Patches
- Matrix polymers, adhesives, enhancers
- In-vitro permeation
- Stability optimization
“Transdermal patch development demands precision—from drug selection to skin compatibility. At SmaBio Labs, we turn complexity into patient-friendly, stable, and scalable solutions.”
Quality · Process · Compliance
Science-driven, regulator-ready, partner-first.
- QbD- and DoE-based approach
- ICH Zones I–IVb stability
- GMP-compliant CTM Phase I–II
- Classified cleanrooms
- Aliquoting under cGMP
- Successful client audits