Timeline & RACI (Milestones, Roles, and Gates)

Short Description:

A milestone-driven plan with clear client vs. manufacturer inputs/outputs and acceptance criteria. Weekly cadence with risk log updates by default.

Product Video Sample Diagram Performance & Features Work station details Technical Parameters

Predictable lead times: stage acceptance + parameter freeze reduces back-and-forth.
Transparent communication: Gantt rhythm + weekly reports; decision points pre-aligned.
Supply-chain alignment: long-lead packaging and key excipients secured early.
Expedite options: parallelize activities (where validated) to shorten time-to-market.

Phase	Duration (working days)	Client Inputs	Our Outputs	Gate
T0 Kickoff & NDA	1–3	Target dose/size, markets, annual volume	Project plan, data request list, initial risk scan	Project Go
Feasibility / Concept	5–10	API/excipient info, flavor direction	Concept formulas, DoE plan	Concept Review
Prototyping	5–10	Review feedback	1–2 rounds of samples, initial COA	Sample Approval
Pilot-1	10–15	Packaging intent, coding/label needs	Pilot-1 batch, accel stability plan	Param Freeze (v1)
Pilot-2	15–25	Final pack decision	Pilot-2 batch, OQ/PQ draft	Final Freeze
Launch Prep	5–10	PO / delivery rhythm	Final SOPs, QC plan, sampling scheme, retain plan	FAI Approval
Commercial Runs	As scheduled	—	Shipment, COA, traceability pack	Delivery Complete

SLA (communication): responses within 24 h on business days; initial deviation assessment within 48 h.
On-time delivery: target ≥95% against agreed production schedule.
Change control: any change to formula/process/packaging requires written approval and impact assessment on CQAs.
Data & documentation: COA, batch-record summary, key raw data, retain IDs; optional extended validation (IQ/OQ/PQ/cleaning) and third-party testing coordination.

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