GMP & GCP Quality Services
Quality Assurance, Audits, and Inspection Readiness
From first IND to commercial supply, Celito hardens your manufacturing and clinical operations against regulatory risk.
Why GMP & GCP Compliance Matters
Whether you are producing clinical material or running multi-site trials, a single compliance mis-step can derail timelines and valuations. Our specialists have supported dozens of successful FDA, EMA, and MHRA inspections so you stay on track.
What We Deliver
GMP Quality Assurance
- Facility and process gap assessments benchmarked to current FDA/EMA/MHRA expectations.
- Phase-appropriate SOP framework that scales from engineering runs through commercial lots.
- Supplier & CMO audits covering qualification, ongoing surveillance, and quality agreements.
- Data-integrity checks (ALCOA +) across batch records, LIMS, and manufacturing systems.
GCP Quality Oversight
- Risk-based clinical QA plans tailored to study complexity and indication.
- Clinical Investigator (CI) site and Service Provider (vendor) audits for compliance, safety, and TMF accuracy.
- Proactive inspection-readiness drills, including mock interviews, document triage, and real-time “war room” coordination.
- Post-inspection CAPA management with corrective actions, effectiveness verification, and dashboards.
Audit & Inspection Readiness
- Full-scale mock inspections to surface gaps before the agency arrives.
- Live evidence rooms, document runners, and rapid issue triage during inspections.
- End-to-end CAPA tracking and closure to eliminate repeat findings.
Continuous Quality Improvement
- KPI dashboards for deviations, CAPAs, batch records, and eTMF completeness.
- Root-cause analysis workshops that embed a preventive quality culture.
- Role-based training curricula mapped to evolving regulations and responsibilities.
Our 4‑Step Methodology
Assess
Baseline GMP/GCP audit, risk scoring, and prioritized remediation roadmap.
Architect
Future-state process flows and Role × System × Data blueprint.
Implement
SOP authoring, validated configuration, migration, and staff training.
Advance
Metrics reviews, periodic internal audits, and continuous-improvement cycles.
Flexible Ways to Engage
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Model
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Typical Use Case
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Commitment
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|---|---|---|
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Quality Accelerator Program
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Series A–C biotechs needing GMP & GCP uplift in < 4 months
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16 weeks
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Fractional Head of Quality
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Interim leadership plus inspection prep
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1–2 days / week
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Audit & Inspection Support
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Global audits, Service Provider (vendor) oversight, and on-call SWAT team for inspections
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Project-based
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Analytics Accelerator
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Dashboards & signal finder on trial data
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6‑8 weeks
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Proven Outcomes
Zero major observations across multiple FDA and EMA inspections.
25% faster deviation closure after implementing our KPI dashboard.
90% CAPA effectiveness within the first audit cycle.