End to END PHARMACEUTICAL GUMMY DRUG PRODUCT DEVELOPMENT
1. Product Definition, Regulatory Framing & Feasibility
1. Product Definition, Regulatory Framing & Feasibility
Target product profile, API assessment, dose load, reference products, preliminary regulatory and commercial assumptions.
2. Prototype & Taste-Masking Strategy
1. Product Definition, Regulatory Framing & Feasibility
Formulation screening, taste-masking approach, texture, flavor and early process assessment
3. Product Development, Process and Analytical Strategy
3. Product Development, Process and Analytical Strategy
Critical material and process parameters, analytical strategy, packaging selection and stability design
4. Pilot Scale-Up & Stability set down
3. Product Development, Process and Analytical Strategy
Pilot manufacturing, process learning, preliminary stability and preparation for technology transfer
5. Tech Transfer & Regulatory Execution
Transfer-package preparation, CDMO coordination, analytical validation, GMP readiness, BA/BE or clinical support where required, and regulatory dossier activities through qualified partners.
6. Commercial Manufacturing, Launch & Supply Coordination
Commercial GMP manufacturing, packaging, launch preparation and ongoing supply coordination through qualified partners