KSA Technical Services LLC

Where Knowledge,
Skills, and Ability
Deliver Results.

An independent technical consulting practice delivering program governance, GMP lifecycle support, quality assurance, supply chain coordination, process engineering, and operational readiness services for pharmaceutical and life sciences organizations. Based in San Diego, California. Founded on integrity and professional accountability.

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At a Glance
10+ Years in regulated GMP and life sciences environments
8 Defined service areas across the regulated product lifecycle
Phase 1 through commercial-scale manufacturing — full lifecycle coverage
WY LLC Registered entity — insured, governed, and audit-ready from day one
What We Deliver

Service Capabilities Tailored to Your Program

Every engagement is led personally by Kory Alpichi. No handoffs, no junior staff, no diluted attention. Knowledge-driven capability applied directly to your program from day one, governed by a written agreement.

Pharmaceutical laboratory with regulated manufacturing equipment
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 — scoped to each engagement.

  • Integrated master schedules in Smartsheet & MS Project
  • Program governance and phase gate coordination
  • Executive stakeholder reporting and decision support
  • Risk identification, escalation, and closure tracking
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GMP cleanroom manufacturing facility qualification and validation
02

GMP Compliance & CQV

Coordination and execution support across the commissioning, qualification, and validation lifecycle for GMP manufacturing equipment and facilities. Work is performed within the authority assigned by the client and aligned with applicable regulations and guidance.

  • URS, IQ, OQ, PQ protocol coordination and execution support
  • Change control, FMEA, and deviation management
  • SCADA and 21 CFR Part 11 alignment
  • Inspection readiness support and gap remediation
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Quality assurance laboratory testing and analysis
03

Quality Assurance Support

Quality system coordination and documentation support to strengthen compliance posture across GMP manufacturing environments. Services are advisory and coordination in nature, within the authority defined by each engagement.

  • Quality management system coordination
  • SOP authorship, harmonization, and review support
  • CAPA tracking and effectiveness monitoring
  • Audit readiness preparation and gap assessment support
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Supply chain vendor management and logistics coordination
04

Supply Chain & Vendor Management

Vendor qualification support, procurement coordination, and supply chain risk management for regulated pharmaceutical and life sciences programs. Advisory scope focused on documentation readiness, qualification, and continuity planning.

  • CMO qualification support and technical agreement coordination
  • Vendor deliverable tracking and day-to-day coordination
  • Supply chain risk identification and mitigation advisory
  • Raw material and consumable qualification support
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Process engineering and scale-up development in regulated manufacturing
05

Process Engineering & Development

Process engineering coordination and scale-up support for pharmaceutical and life sciences programs transitioning from development to GMP manufacturing. Grounded in a decade of hands-on chemical engineering experience across multiple process modalities.

  • R&D to GMP process transfer coordination
  • Scale-up planning support and milestone tracking
  • DOE coordination and process improvement facilitation
  • Equipment and process qualification documentation support
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Operational readiness and manufacturing startup coordination
06

Operational Readiness

Integrated planning and coordination support for the transition from project delivery through commissioning, qualification, operational preparation, and manufacturing startup. Focus on dependency management, ownership clarity, and readiness evidence.

  • Readiness deliverable tracking across multi-functional workstreams
  • System and area handover coordination
  • Risk escalation and schedule interface management
  • Transition-to-operations planning within assigned authority
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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 coordination, quality assurance support, supply chain management, process engineering, and documentation rigor — forged in GMP environments where precision is not optional.

A bility

The capacity to coordinate, deliver, and adapt under pressure. We measure ourselves by the quality of what we contribute — transparent reporting, disciplined documentation, proactive escalation, and a steady commitment to the programs we serve.

* Engagement Terms and Scope Limitations. KSA Technical Services LLC provides independent consulting services to pharmaceutical and life sciences organizations. All engagements are governed by a written service agreement executed prior to commencement of any work. Services described on this website represent areas of consulting capability and defined scope of work offered — not guarantees of specific regulatory, inspection, validation, schedule, cost, or commercial outcomes. KSA Technical Services LLC does not act as engineer of record, quality-unit authority, product-release agent, regulatory agent, licensed contractor, legal counsel, or financial advisor. Client identities, internal deliverables, and confidential information are not disclosed without appropriate written authorization. Submission of an inquiry does not establish a consulting relationship, engagement, or confidentiality obligation.