version: 1 defaults: method: mckinsey_market methods: mckinsey_market: name: McKinsey-style market and strategy research best_for: - market research - investment memo - competitive landscape structure_principle: Pyramid principle with MECE chapter coverage. task_axes: - literature - regulatory - patents - market - counter framework_sections: - central_thesis - chapter_outline - alternative_frameworks - risks_and_dependencies gmp_gap_assessment: name: GMP consulting gap assessment and remediation best_for: - GMP audit remediation - quality system consulting - supplier audit CAPA structure_principle: Regulation-to-gap-to-risk-to-CAPA pathway. task_axes: - regulatory_gap - risk_classification - capa_design - ownership_timeline - verification_evidence - counter framework_sections: - regulatory_baseline - gap_matrix - risk_ranking - capa_roadmap - verification_plan cmc_process_risk: name: CMC process and scale-up risk assessment best_for: - process development - tech transfer - manufacturing readiness structure_principle: Process-flow, CQA/CPP, scale-up, control strategy. task_axes: - process_flow - cqa_cpp - scale_up_risk - control_strategy - supply_chain - counter framework_sections: - process_map - critical_quality_attributes - critical_process_parameters - scale_up_risks - control_strategy rd_go_no_go: name: R&D go/no-go decision research best_for: - project initiation - modality selection - development strategy structure_principle: Scientific rationale, proof-of-concept, IP/FTO, development path, go/no-go criteria. task_axes: - scientific_rationale - poc_evidence - ip_fto - development_path - commercial_window - counter framework_sections: - scientific_rationale - evidence_threshold - ip_fto - development_plan - go_no_go_criteria management_consulting: name: Management consulting diagnostic and operating model best_for: - organization diagnosis - operating model design - governance and process improvement structure_principle: Diagnostic baseline, capability gaps, operating model, roadmap, governance. task_axes: - current_state - capability_gap - operating_model - governance - implementation_roadmap - counter framework_sections: - current_state_diagnosis - capability_gap - future_state_model - roadmap - governance_metrics gmp_quality_operations_diagnosis: name: GMP quality, manufacturing process, and operations diagnosis best_for: - GMP audit remediation from client materials - quality system diagnosis - manufacturing process system diagnosis - operations management transformation structure_principle: Start from site audit evidence, map findings to regulatory baseline and operating model gaps, then design short/mid/long-term remediation. task_axes: - input_material_findings - nmpa_fda_ema_ich_who_baseline - quality_system_gap - manufacturing_process_risk - operations_management_gap - team_capability - capa_roadmap - verification_evidence - counter framework_sections: - material_evidence_map - regulatory_and_best_practice_baseline - quality_system_gap_matrix - manufacturing_process_risk_map - operations_management_diagnosis - people_and_capability_diagnosis - short_mid_long_term_roadmap - governance_and_verification_plan