Science & Validation
Rigorous Scientific Validation
Our technology platforms are supported by extensive stability data, pharmaceutical-grade manufacturing standards, and deep regulatory expertise.
Stability Data
Pharmaceutical formulation stability is critical for commercial viability. Our platforms demonstrate industry-leading stability profiles validated through rigorous long-term testing protocols.
Nanoemulsion Stability
18+ Months
Validated stability for nanoemulsion compositions under standard pharmaceutical storage conditions. Particle size, zeta potential, and active ingredient concentration maintained within specification throughout the testing period.
CBD Formulation Stability
4+ Years
Our CBD nanoemulsion formulations have demonstrated exceptional long-term stability exceeding four years, proving the robustness of our nanoemulsion platform for commercial pharmaceutical applications.
Nano-Suspension Particles
<10nm Consistent
Reproducible particle size below 10nm across production batches, validated through dynamic light scattering (DLS) and confirmed by electron microscopy.
Stability Testing Timeline
Initial Formulation
Baseline characterization and specification setting
3-Month Check
Accelerated stability conditions validated
6-Month Review
All parameters within specification
12-Month Milestone
Long-term stability confirmed
18+ Month Validation
Commercial stability demonstrated
Quality Systems & Manufacturing Standards
Our manufacturing operations follow rigorous pharmaceutical quality standards, ensuring consistent pharmaceutical-grade output.
Quality Control Processes
Multi-stage quality control throughout the manufacturing process ensures every batch meets pharmaceutical specifications.
- Raw material verification
- In-process quality checks
- Final product testing
- Batch release documentation
Analytical Methods
State-of-the-art analytical equipment and validated methods for comprehensive characterization of nanoemulsions and nanoparticles.
- Dynamic light scattering (DLS)
- Zeta potential analysis
- HPLC active content assay
- Electron microscopy validation
Stability Testing
ICH-compliant stability testing programs providing robust data packages to support regulatory submissions globally.
- ICH Q1A(R2) compliant
- Accelerated & long-term studies
- Photostability testing
- In-use stability assessment
Documentation Standards
Comprehensive documentation systems meeting regulatory requirements across multiple jurisdictions for seamless technology transfer.
- Batch manufacturing records
- Standard operating procedures
- Validation protocols & reports
- Regulatory submission packages
Continuous Improvement
Systematic process optimization and quality improvement programs maintaining our position at the forefront of nano-pharmaceutical manufacturing.
- Process optimization studies
- Root cause analysis systems
- CAPA implementation
- Technology advancement program
Regulatory Pathway Expertise
Navigating the regulatory landscape for nanotechnology-based pharmaceuticals requires specialized expertise. Our team provides comprehensive regulatory support to accelerate your path to market.
Key Regulatory Capabilities
QA
Quality Assured
ICH
Compliant Studies
FDA
Strategy Support
Global
Market Access
Research & Publications
Our scientific team actively contributes to the advancement of pharmaceutical nanotechnology. Technical publications and white papers are available upon request for qualified pharmaceutical partners.
For access to our technical documentation, stability data packages, and research publications, please contact our scientific team through our partnership inquiry process.
Request Technical DocumentationReview Our Scientific Credentials
Interested in detailed technical data, stability reports, or regulatory documentation? Our team is ready to provide comprehensive information for qualified partners.
Contact Scientific Team