KSA Technical Services

Where Knowledge,
Skills, and Ability
Deliver Results.

An independent technical advisory firm delivering program governance, GMP compliance support, and regulated lifecycle advisory for pharmaceutical and life sciences organizations. Based in San Diego, California. Founded on integrity and professional accountability.

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Delivery Track Record
10+ Years in regulated GMP and life sciences environments
Programs spanning Phase 1 clinical development through commercial-scale operations
Cross-functional coordination across Quality, Manufacturing, Regulatory, and Engineering
Engagements structured to support client audit-readiness objectives from day one
What We Deliver

Our Services are Tailored to Your Unique Needs

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

Program Governance and Oversight

Structured governance and cross-functional coordination for complex, multi-workstream programs in regulated manufacturing and clinical development. Integrated scheduling, RAID tracking, KPI reporting, and executive stakeholder support.

  • 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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Our Approach

The KSA Standard

Every engagement, every deliverable, and every relationship is anchored in three principles that define how we show up and what clients can expect from us.

K
nowledge

Deep domain expertise earned over a decade across pharmaceutical manufacturing, clinical development, process engineering, and regulatory compliance. We do not generalize. We specialize, and that specificity creates value.

S
kills

Proven, applied capabilities in program governance, CQV execution, CMC management, stakeholder alignment, and documentation rigor. Skills forged in GMP environments where precision is not optional.

A
bility

The capacity to lead, adapt, and deliver under pressure. Ability is character made visible through outcomes. We measure ourselves not by effort, but by the results our clients achieve when we leave.