Consulting.

The consulting practice is led by Tristen Stewart, whose pharmaceutical operations career began inside Genentech’s South San Francisco campus — where, at twenty-five, he became the youngest consultant on a team of practitioners two decades his senior. The senior consultants who mentored him taught more than process: they taught how to structure documentation, decisions, and engagements so the work could be audited, inherited, and trusted long after the consultant left the building.

The professional experience that informs every engagement spans Ferring, Sanofi, CSL Behring, Fuji-Film Diosynth, and Genentech — in roles across quality assurance, validation, contamination control, and manufacturing engineering. The same documentation discipline, change control, and follow-through that defines those environments now defines every TS MGMT engagement.

• cGMP compliance gap assessments, audit readiness, and CAPA execution
• Computer System Validation (CSV) and 21 CFR Part 11 alignment
• Electronic batch record (EBR) deployment and process digitization
• PFMEA & DFMEA risk assessment and contamination control strategy
• Tech transfer protocols and equipment onboarding
• Vendor and supplier qualification programs
• Regulatory submission support and pre-inspection preparation

Every engagement begins with a focused scoping conversation — not a sales pitch. We listen to the operational pain, map it against current state, and propose a path that respects budget, headcount, and timeline realities.

Deliverables are documented, traceable, and audit-ready from day one. The same discipline that produces clean batch records produces clean consulting work.