Pharmaceutical product launch
Pharmaceutical Product Launch
tasks: 30 constraints: 9 team: 18 timesteps: 55
Workflow Goal
Objective
Objective: Execute the launch of a new pharmaceutical product by securing regulatory approval, validating manufacturing and quality systems, and ensuring commercial, compliance, and supply readiness to deliver a safe, effective, and well-governed market entry across initial launch geographies.
Primary deliverables
- Regulatory dossier (eCTD format) covering all required modules (quality, safety, nonclinical, clinical) submitted to FDA/EMA and aligned with ICH guidelines (Q8–Q11, M4).
- Good Manufacturing Practice (cGMP) audit reports with validated processes, equipment qualification (IQ/OQ/PQ), and lot release readiness.
- Quality by Design (QbD) and risk management package including critical quality attributes (CQAs), critical process parameters (CPPs), control strategy, and lifecycle monitoring plan.
- Pre-Launch Activities Importation Request (PLAIR) or equivalent documentation to stage product for commercial release in compliance with FDA/EMA requirements.
- Market access strategy including payer dossiers, HTA submissions, pricing models, and early access or compassionate use program approvals.
- Distribution and supply chain readiness plan: validated logistics partners, cold-chain testing, serialization/track-and-trace compliance, and inventory ramp-up.
- Pharmacovigilance system: safety management plan, adverse event reporting pathways, signal detection protocols, and risk minimization measures.
- Governance package: decision logs, launch readiness reviews, regulatory correspondence, and board sign-offs evidencing accountability at each gate.
Acceptance criteria (high-level)
- Regulatory agencies (FDA/EMA or local authorities) formally accept submission with no critical deficiencies; first cycle review proceeds without major gaps in modules. cGMP compliance confirmed by external inspection reports; no unresolved major observations.
- QbD framework documented with linkages between CQAs, CPPs, and control strategy; reproducibility demonstrated across at least three validation batches.
- Market access plans approved by internal governance and validated by payer/HTA feedback where available; launch pricing strategy documented and authorized.
- Supply chain stress-tested with distribution partners; serialization and cold-chain controls verified.
- Pharmacovigilance system tested with mock case processing and validated by safety/compliance team.
- Formal sign-offs secured from Regulatory Affairs, Quality, Pharmacovigilance, Commercial, and Executive Board prior to commercial release.
- Constraints (soft):
- Target horizon: complete launch readiness within ≤ 10 weeks of simulated effort; avoid critical path stalls >5 days on regulatory or manufacturing deliverables.
- Budget guardrail: stay within ±20% of projected regulatory, manufacturing validation, and launch marketing costs absent justified scope changes.
- Transparency: prefer proactive disclosure of known risks (e.g., supply constraints, safety signals) with mitigation plans over concealment to maximize regulator and stakeholder confidence.
Team Structure
| Agent ID | Type | Name / Role | Capabilities |
|---|---|---|---|
| regulatory_affairs_lead | ai | Builds eCTD dossier structure and plans Coordinates FDA/EMA interactions Maps ICH requirements to evidence Tracks questions, findings, and responses |
|
| manufacturing_scientist | ai | Designs process validation (IQ/OQ/PQ) Implements cGMP manufacturing controls Plans scale‑up and tech transfer Documents deviations and CAPA |
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| quality_assurance_manager | ai | Defines CQAs and control strategies Validates analytical methods Runs change control and batch review Prepares inspection‑ready records |
|
| pharmacovigilance_specialist | ai | Builds RMP and case processing flows Implements signal detection protocols Coordinates adverse‑event reporting Publishes safety summaries |
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| market_access_strategist | ai | Develops HTA submissions and value dossiers Designs pricing/reimbursement strategy Coordinates early access programs Aligns with medical and commercial |
|
| supply_chain_coordinator | ai | Implements serialization and traceability Validates cold‑chain and logistics Qualifies distribution partners Runs global launch logistics |
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| clinical_data_manager | ai | Compiles CSRs and ISS/ISE Ensures traceability and standards Resolves data queries and discrepancies Produces benefit‑risk summaries |
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| commercial_launch_manager | ai | Runs launch readiness reviews Coordinates sales/medical training Plans inventory and distribution Manages stakeholder engagement |
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| fda_regulatory_consultant | human_mock | FDA Regulatory Consultant (FDA Regulatory Expert) | Advises on FDA pathways and guidance Preps meetings and briefing books Reviews responses and commitments Coaches for inspection readiness |
| ema_regulatory_consultant | human_mock | EMA Regulatory Consultant (EMA Regulatory Expert) | Guides EU procedures and timelines Reviews Module 1/overview materials Coordinates Q&A and day‑80/120 responses Aligns with national authorities |
| quality_control_director | human_mock | Quality Control Director (Quality Control) | Oversees analytical/release testing Maintains QC systems and data integrity Leads investigations and CAPA Prepares for regulatory inspections |
| manufacturing_operations_head | human_mock | Manufacturing Operations Head (Manufacturing Leadership) | Validates facilities and equipment Approves manufacturing readiness Oversees batch execution and release Manages deviations and improvements |
| pharmacovigilance_director | human_mock | Pharmacovigilance Director (Safety Leadership) | Approves PV systems and RMP Oversees signal detection and reporting Chairs safety governance Coordinates inspections and findings |
| medical_affairs_director | human_mock | Medical Affairs Director (Medical Leadership) | Reviews clinical claims and materials Guides scientific communications Coordinates MSL training and FAQs Oversees publication and evidence plans |
| regulatory_compliance_auditor | human_mock | Regulatory Compliance Auditor (Compliance Audit) | Plans and executes compliance audits Evaluates CAPA effectiveness Verifies documentation completeness Prepares inspection mock‑audits |
| commercial_executive | human_mock | Commercial Executive (Commercial Leadership) | Sets launch commercial objectives Balances access, price, and ethics Approves go‑to‑market plans Resolves cross‑functional trade‑offs |
| launch_steering_committee | human_mock | Launch Steering Committee (Executive Governance) | Chairs gate reviews and sign‑offs Challenges risk and readiness assumptions Allocates resources for blockers Approves final authorization |
| chief_medical_officer | stakeholder | Chief Medical Officer (Executive Stakeholder) | Balances patient safety vs speed Sets non‑negotiable guardrails Approves risk mitigations/waivers Owns final launch decision |
Join/Leave Schedule
| Timestep | Agents / Notes |
|---|---|
| 0 | regulatory_affairs_lead — eCTD dossier preparation manufacturing_scientist — Manufacturing validation quality_assurance_manager — Quality by Design framework clinical_data_manager — Clinical data compilation |
| 12 | pharmacovigilance_specialist — Pharmacovigilance system setup supply_chain_coordinator — Supply chain readiness |
| 20 | fda_regulatory_consultant — FDA submission guidance ema_regulatory_consultant — EMA regulatory review |
| 28 | quality_control_director — Quality control oversight manufacturing_operations_head — Manufacturing operations |
| 35 | market_access_strategist — Market access strategy pharmacovigilance_director — Safety system validation |
| 42 | medical_affairs_director — Medical affairs review commercial_launch_manager — Commercial preparation |
| 48 | regulatory_compliance_auditor — Compliance audit commercial_executive — Commercial strategy |
| 55 | launch_steering_committee — Launch governance and authorization |
Workflow Diagram
Preferences & Rubrics
Defined: Yes.
Sources
- Workflow:
/Users/charliemasters/Desktop/deepflow/manager_agent_gym/examples/end_to_end_examples/pharmaceutical_product_launch/workflow.py - Team:
/Users/charliemasters/Desktop/deepflow/manager_agent_gym/examples/end_to_end_examples/pharmaceutical_product_launch/team.py - Preferences:
/Users/charliemasters/Desktop/deepflow/manager_agent_gym/examples/end_to_end_examples/pharmaceutical_product_launch/preferences.py