Cruz Pharma Expert Consultancy (CPEC) supports manufacturers and stakeholders with sterile/aseptic operations, Annex 1 alignment, CAPEX project execution, and people capability development. Structured. Evidence-based. Audit-ready.
A manufacturing-led approach that balances compliance, practicality, and operational performance—so your systems work on the shopfloor and stand up in audits.
Annex 1 / PIC/S / WHO alignment with documentation discipline, data integrity, and clear acceptance criteria.
Structured governance, weekly cadence, ownership mapping, and practical risk controls that teams can sustain.
OEE thinking, downtime insights, capacity balancing, and capability development—without compromising GMP.
Modular support—engage for a focused deliverable or a full program.
OEE framework, downtime Pareto, capacity planning, weekly governance cadence, and management storytelling dashboards.
Annex 1 readiness, CCS buildout, aseptic behaviour program, EM strategy, media fill governance, and gap closure execution.
Concept-to-commissioning support: URS/FRS, risk registers, board-ready business cases, and stakeholder alignment.
Competency matrices, training roadmaps, aseptic technique programs, and cross-functional capability building.
Digitised forms, approval workflows, dashboards and audit trails for maintenance, production, and compliance processes.
Inspection preparation, response strategy, CAPA governance, and investigation leadership for sterile manufacturing topics.
A visual overview of the work environments and consulting themes CPEC supports.
Professional service pricing varies by scope. These tiers help you estimate engagement size.
Best for: quick diagnostic + action plan
Best for: Annex 1 readiness / CCS execution
Best for: board-ready delivery support
*Pricing is indicative. Final quotation will depend on site count, scope depth, urgency, and deliverables.
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Common questions from hospitals, institutions, and internal manufacturing teams.
Yes. CPEC can support end-to-end—from gap assessment to CCS structure, risk tools (FMEA), EM strategy alignment, governance cadence, and execution coaching.
Yes. Support includes readiness checks, evidence mapping, CAPA governance, investigation coaching, and inspection response strategy for sterile topics.
Yes. Training can be delivered as modules (aseptic behaviour, contamination control, data integrity, governance) with competency matrices and assessments.
No. While sterile/aseptic is a core strength, CPEC also supports operational excellence and governance for other dosage forms and manufacturing environments.
Send your request and I’ll respond with the next steps, scope options, and a quotation approach.
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Klang, Selangor (replace with full business address anytime)