KSA Advisory Group

Where Knowledge,
Skills, and Ability
Deliver Results.

A technical advisory firm specializing in Technical Program Management, GMP Compliance, and regulated project delivery for pharmaceutical and life sciences organizations. Based in San Diego. Founded on integrity and professional accountability.

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Delivery Track Record
10+ Years in regulated environments
50+ GMP programs delivered
25+ Cross-functional stakeholders managed
100% We design deliverables to support client audit readiness objectives.
What We Deliver

Purpose-Built Advisory Services

Every engagement is led personally by Kory Alpichi. No handoffs, no junior staff, no diluted attention. You receive knowledge-driven capability applied directly to your program from day one.

01

Technical Program Management

End-to-end oversight of complex, multi-workstream programs in regulated manufacturing and clinical development. Governance frameworks, RAID logs, and KPI dashboards that hold teams accountable.

  • Integrated master schedules in Smartsheet & MS Project
  • Program governance and phase gate management
  • Executive stakeholder reporting and decision support
  • Risk identification, escalation, and closure tracking
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02

GMP Compliance & CQV

Commission, qualify, and validate GMP manufacturing equipment and facilities to 21 CFR and ICH standards. Audit-ready documentation from URS through final regulatory turnover.

  • CQV lifecycle: URS, IQ, OQ, PQ protocol authorship and execution
  • Change control, FMEA, and deviation management
  • SCADA and OT/IT cybersecurity alignment
  • Inspection readiness and gap remediation
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03

CMC & Technology Transfer

Full program management of CMC activities from Phase 1 through commercial scale-up. Vendor selection, tech transfer coordination, and seamless manufacturing transition.

  • Phase 1 and Phase 2 CMC program planning
  • Technology transfer to GMP CMO
  • CMO qualification and supply chain risk mitigation
  • IND/NDA CMC submission alignment
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