How We Work
A structured path from concept to launch
A structured development process helps define scope, decision points, responsibilities, testing needs, risks, and launch-readiness requirements before a program moves deeper into execution.
The 16-step development process
Sixteen steps, four phases
The phases group the work; every step keeps its own decision and deliverable.
Discover
- Clinical / commercial concept
- Feasibility review
- Regulatory / pharmacy pathway
- Formulation feasibility
Develop
- API sourcing
- Cost modeling
- Prototype
- Analytical testing
Validate
- Taste / patient experience
- Stability
- Clinical-development strategy
- Pilot / clinical evidence where applicable
Scale & launch
- Scale-up
- Packaging / branding
- Technology integration
- Launch readiness
Project structure
Every project should have
Definition, named responsibility and control — agreed at the start, revisited at each gate.
Definition
- Scope
- Objectives
- Deliverables
- Timeline
Named responsibility
- Project owner
- Scientific lead
- Clinical lead where applicable
- Operations lead
- Quality representative
Control
- Testing requirements
- Decision gates
- Risk register
Project gates
Thirteen gates from discovery to launch
Each gate is a decision point: continue, adjust, or stop. Nothing advances on assumption.
Discovery
Launch
- Discovery
- Feasibility
- Prototype
- Analytical assessment
- Taste / patient experience
- Formulation optimization
- Stability
- Clinical development
- Evidence generation
- Scale-up
- Packaging
- Technology transfer
- Launch Final gate
At every gate
- Continue
- Adjust
- Stop
