GxP Audit & Advisory for Brand Owners and Sponsors
Independent audit and advisory services for brand owners, sponsors, and companies managing outsourced manufacturing — covering supplier qualification, CMO oversight, quality agreements, clinical compliance, and regulatory submissions across TGA, FDA, EU GMP, PIC/S, and NMPA.
Flagship Service
Supplier & CMO Audits
Independent qualification and oversight of your third-party manufacturing network
Outsourced manufacturing transfers production — not accountability. Regulators hold the brand owner or sponsor responsible for the quality of every product, regardless of who makes it. Vitalane conducts independent GMP audits of contract manufacturers, API suppliers, packaging suppliers, and testing laboratories — providing an objective assessment that protects your product quality and regulatory standing.
Supplier qualification audits (initial and periodic)
CMO GMP compliance audits
API and excipient supplier audits
Contract laboratory (CRO/CLO) audits
Audit reports with risk-rated findings
Supplier corrective action follow-up
Approved supplier list (ASL) support
GMP Audits
Rigorous, independent assessment of your manufacturing operations
GMP audits provide a comprehensive evaluation of your facility, processes, and quality systems against current regulatory standards. Compliance gaps are identified before regulators do, giving you the opportunity to remediate proactively.
Full audit report with risk-rated findings
Corrective action recommendations
Regulatory benchmark comparison
Executive summary for leadership
CSV audits
API PAI audits
Clinical trial distribution site audits
TGAFDAEU GMPNMPA
Mock Inspections
Simulate a real regulatory inspection before the real one
Prepare your team for the pressure and scrutiny of an official inspection. Mock inspections replicate the approach of TGA, FDA, and EU GMP inspectors — including document requests, facility walkthroughs, and personnel interviews.
Inspection readiness score
Simulated inspector Q&A
Document readiness review
Post-inspection debrief and action plan
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Quality & Technical Agreements
Clear contractual frameworks for GMP responsibilities across your supply chain
Quality agreements define who is responsible for what when manufacturing is outsourced. Vitalane drafts, reviews, and negotiates Quality Agreements and Technical Agreements between sponsors, CMOs, suppliers, and distributors — ensuring regulatory obligations are clearly allocated and enforceable.
Know exactly where you stand against current GMP requirements
A structured gap assessment maps your current quality systems against the applicable regulatory framework, producing a prioritised remediation roadmap. Ideal for new facilities, post-merger integration, or preparation for a new market entry.
Gap analysis matrix
Risk-prioritised remediation roadmap
Timeline and resource estimates
Regulatory framework alignment report
TGAFDAEU GMPNMPA
ICH E6(R3) Gap Assessment & Advisory
Prepare your clinical operations for the updated GCP standard
ICH E6(R3) represents a significant evolution in Good Clinical Practice — introducing a risk-based, proportionate approach to clinical trial oversight that demands a genuine review of existing systems and processes. Vitalane provides structured gap assessments and advisory support to help sponsors, CROs, and investigator sites understand what has changed and what needs to change.
ICH E6(R3) gap assessment against current systems
Risk-based monitoring framework review
Quality Management System (QMS) alignment
Protocol and informed consent document review
Investigator site readiness assessment
Remediation roadmap and implementation support
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SOP Writing & Review
Compliant, clear, and audit-ready standard operating procedures
SOPs are authored, reviewed, and updated to meet current GMP expectations. Deep operational experience ensures procedures are not only compliant but practical for your team to follow consistently.
New SOP authoring
Existing SOP gap review
Document control alignment
Training material development
TGAFDAEU GMP
CAPA Management
Robust corrective and preventive action systems that satisfy regulators
Effective CAPA is one of the most scrutinised areas in any GMP inspection. Vitalane helps design, implement, and verify CAPA systems that demonstrate genuine root cause analysis and sustainable corrective action.
CAPA system design or review
Root cause analysis facilitation
Effectiveness check protocols
Regulatory response support
TGAFDAEU GMPNMPA
Investigational Product Supply Chain
GMP and GCP compliance for clinical trial supply from manufacture to site
The supply chain for investigational medicinal products (IMPs) sits at the intersection of GMP and GCP — and is frequently under-resourced. Vitalane provides end-to-end compliance support for IMP manufacture, packaging, labelling, storage, distribution, and returns, ensuring your clinical supply chain meets TGA, FDA, and EU GMP Annex 13 requirements.
IMP manufacturing and packaging compliance review
Annex 13 gap assessment
Clinical supply chain SOP development
IMP labelling review (blinded and open-label)
Temperature-controlled distribution compliance
Returns, reconciliation, and destruction procedures
Qualified Person (QP) release support
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Regulatory Submissions
Expert preparation of dossiers and responses for global regulators
From CTD module preparation to regulatory response letters, Vitalane supports submissions to TGA, PIC/S, FDA, EMA, and NMPA. Documentation is technically sound, clearly written, and strategically positioned.
CTD module preparation
Regulatory query responses
Variation and renewal support
Pre-submission meeting preparation
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GMP Training
Build a compliance culture from the shop floor to the boardroom
Training programmes are tailored to your organisation's role structure and regulatory context. Workshops, e-learning content, and competency assessments build genuine GMP understanding — not just tick-box compliance.
Role-based training programmes
Workshop facilitation
Competency assessment tools
Training record templates
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Process Validation
Documented evidence that your manufacturing process consistently delivers
Process validation programmes are designed and executed to satisfy TGA, FDA, and EU GMP expectations. From prospective validation of new processes to concurrent and retrospective reviews, the validation lifecycle is scientifically sound and inspection-ready.
Validation master plan (VMP)
Process validation protocols and reports
Statistical analysis of critical quality attributes
Continued process verification (CPV) programmes
Regulatory submission support
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Cleaning Validation
Demonstrate your equipment is clean, safe, and cross-contamination free
Cleaning validation services cover the full lifecycle — from worst-case product selection and acceptance limit calculations through to protocol execution and report authoring — applying current regulatory guidance including EMA and FDA cleaning validation expectations.
Cleaning validation risk assessment
Acceptance limit calculations (MACO/HBEL)
Cleaning validation protocols and reports
Swab and rinse sampling strategies
Cleaning procedure review and optimisation
TGAFDAEU GMPEMA
Annual Supplier Assurance Program
Structured, risk-ranked oversight of your approved supplier network — every year
A one-off audit tells you where a supplier stood on the day. An annual assurance program tells you whether your supplier network is improving, deteriorating, or drifting — and gives regulators evidence of sustained, systematic oversight. Vitalane designs and delivers annual supplier assurance programs that align audit frequency and depth to each supplier's risk profile, covering your full approved supplier list.
Risk-ranked audit schedule across your approved supplier list
Annual audit plan aligned to supplier criticality and risk tier
On-site and remote supplier audits (as scheduled)
Audit reports with risk-rated findings for each supplier
CAPA tracking and close-out verification
Year-end supplier performance summary report
Approved supplier list (ASL) maintenance support
Escalation protocol for critical findings
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Risk-Ranked Findings & CAPA Close-Out
Audit findings that drive action — tracked through to verified close-out
An audit report is only as useful as the action it generates. Vitalane delivers findings classified by risk severity — Critical, Major, and Minor — with clear remediation guidance for each. Where required, Vitalane supports the full CAPA lifecycle: root cause analysis, corrective action design, implementation verification, and documented close-out that satisfies regulatory scrutiny.
Risk-ranked audit findings (Critical / Major / Minor)
Root cause analysis facilitation for Critical and Major findings
CAPA plan development and review
Implementation support and progress tracking
Effectiveness check design and execution
Documented CAPA close-out with evidence review
Regulatory response support where findings are inspection-related
TGAFDAEU GMPPIC/S
Computer System Validation
Compliant CSV and data integrity programmes for GxP-regulated systems
End-to-end computer system validation (CSV) services are aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11. From validation planning and risk classification through to IQ/OQ/PQ execution and periodic review, computerised systems are held to current data integrity expectations.
CSV validation master plan
Risk-based system classification (GAMP 5)
User requirements specification (URS)
IQ, OQ, and PQ protocols and reports
Data integrity gap assessment
21 CFR Part 11 / Annex 11 compliance review
TGAFDAEU GMP
How Vitalane Works
A structured engagement model designed to deliver measurable compliance outcomes.
01
Discovery Call
Every engagement begins with a confidential consultation to understand your regulatory context, current challenges, and objectives.
02
Scoping & Proposal
The engagement scope, deliverables, timeline, and fees are defined in a clear written proposal.
03
On-site or Remote Engagement
The agreed work is conducted on-site at your facility or remotely, depending on the service.
04
Reporting & Remediation Support
Findings are delivered with actionable recommendations, with ongoing availability to support your remediation efforts.
Ready to Strengthen Your GMP Compliance?
Speak with Bright directly about your specific regulatory challenges.
