Clinical & Commercial Manufacturing
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Integrated Clinical & Commercial Manufacturing
One Team, One Journey: From Lab to Market
At Tioga Research, we've eliminated the traditional handoff challenges between R&D and manufacturing. Through our parent company Encube Ethicals (Leading Topical Pharmaceutical Manufacturer in India | Encube Ethicals), we operate as a single, unified team guiding your topical products through every development stage—from initial concept to global commercial supply.
The Tioga-Encube Advantage
Accessing the world’s largest topical-only commercial manufacturing facility isn’t just about capacity—it’s about continuity. The same scientific expertise that optimizes your formulation seamlessly transitions to production scale, preserving critical insights and eliminating knowledge gaps.
Our Integrated Support Includes:
Scientific Continuity
The same team that develops your formulation guides its scale-up, ensuring no knowledge is lost in transition
Analytical Excellence
Method transfer, validation, and stability studies following ICH guidelines
Scale-Up Optimization
Formulation refinements specifically designed for commercial production realities
Regulatory Navigation
Cohesive support for registration batches and regulatory submissions
Manufacturing Capabilities
Our integrated facilities support your product journey through:
- Process development and optimization
- Clinical trial material production
- Registration and validation batches
- Commercial-scale manufacturing
- Primary and secondary packaging
Our few benefits
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Technical Development
Preformulation & Analytical:
Analytical method development and verification; assessments of ingredient compatibilities; solubility measurements; gauging of competitive product performances.
Formulation Innovation:
Assessment & improvement of a current skin-applied formulation; formulation concept & library design.
Skin Permeation Measurements:
Traditional diffusion cell studies using human cadaver skin (IVPT), synthetic membranes (IVRT), and specialized tissue models.
High Throughput Experimentation:
Leveraging our proprietary platforms including INSIGHT™, STORM™, FUROR™, TEMPEST™, and TORNADO™
Refinement & Optimization
Formulation Optimization:
QbD experiments, robustness assessment, excipient sourcing.
Performance Attributes:
Physical property measurements, esthetic evaluations.
Patent Support:
Freedom-to-operate engineering, patenting strategy, experimental data for claims.
Stability Testing:
Formal and informal stability assessments under normal and accelerated conditions
