— PLATFORM SERVICES
Four service modules.
One inspection-ready platform.
Each RelyAInt service module is a structured workflow —
AI-assisted analysis, platform-enforced governance, and inspection-defensible deliverables.
Select any module to see what’s included.
— SERVICE MODULES
What’s inside the platform
Click any service to see what we do, what you receive, and which regulatory standards apply.
01
Regulatory GAP Assessment
Objective, comprehensive view of your compliance posture against FDA, EMA, and global regulatory standards — with a risk-classified finding register.
What we do
Regulatory requirement mapping across FDA, EMA, and ISO standards
Evidence-based control review performed by your team within the platform's structured workflow
Risk-prioritised GAP identification and impact quantification
Inspection-defensible reporting with full audit trail
What you receive
Structured GAP register in your client portal
Risk-classified findings — Critical, Major, Minor
Advisory remediation guidance with sequenced actions
Executive summary and technical inspector report
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
02
Validation & CSV Advisory
Lifecycle gap analysis, risk-based validation calibration, and CSA transition roadmaps — from legacy system hardening to audit-defensible traceability matrices.
What we do
Lifecycle GAP analysis against full GxP lifecycle requirements
Risk-based validation calibration targeting specific vulnerabilities
Legacy system hardening with compensatory controls
CSA transition from paper-heavy CSV to modern assurance
What you receive
Validation maturity assessment report
Short-term tactical remediation plan
Long-term strategic upgrade roadmap
Audit-defensible traceability matrix
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
03
Data Integrity Assurance
ALCOA+ lifecycle mapping, audit trail assessment, and root cause analysis — structured to produce a CAPA package that satisfies regulatory scrutiny.
What we do
Lifecycle vulnerability mapping across full data flow
ALCOA+ alignment audit against all GxP data standards
AI-assisted root cause analysis surfaced for your team to review and confirm.
Legacy data remediation with compensatory controls
What you receive
Structured DI GAP register with severity classification
CAPA package ready for regulator submission
Remediation sequence prioritised by risk impact
Executive and technical report outputs
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
04
Compliance Readiness Programs
Inspection simulations, cross-jurisdiction regulatory mapping, and SME coaching — structured preparation for FDA, EMA, MHRA, SAHPRA, and TGA audit events.
What we do
Cross-market regulatory mapping and delta analysis
Jurisdiction-specific inspection style simulation
Technical dossier review against new market thresholds
Inspection simulation guided by the platform's structured readiness workflow
What you receive
Market entry risk roadmap with priority showstoppers
Short-term bridge SOPs and interim governance measures
Long-term QMS harmonisation plan
Approval-ready playbook for SMEs and leadership
All regulatory applicability and GAP determinations are confirmed by qualified human reviewers.
$500k+
Average cost of a single FDA 483 observation
in remediation, delays, and reputational impact
$400/hr
Traditional regulatory consultancy rate
a 6-week GAP assessment costs $40,000–$80,000+
48hrs
RelyAInt average findings delivery
vs. weeks with traditional consultancy engagements
VS. Traditional
Consulting
Consulting
RelyAInt Growth — $2,500/mo · 10 assessments vs
Traditional firm — $40,000–$80,000 per engagement
Up to 95% less per assessment
Starter
$1,500/mo
5 assessment credits per month
Full platform access
AI-assisted GAP assessments
Findings and actions workflow
Client portal access
Expert review escalation — on demand
Most popular
Growth
$2,500/mo
10 assessment credits per month
Everything in Starter
Priority expert review queue
Multi-system validation support
Inspection readiness programme
Dedicated account support
Enterprise
$4,500/mo
20 assessment credits per month
Everything in Growth
Unlimited expert review requests
Multi-site and CDMO coverage
Custom regulatory workflows
Fixed-price GAP assessments from $7,500
What is an assessment credit? One credit = one complete structured assessment module — a full GAP assessment, a data integrity review, a CSV lifecycle analysis, or a compliance readiness programme. Your team manages the full workflow — reviewing findings, responding to actions, and uploading evidence — directly inside the platform..
— EXPERT REVIEW
Need a qualified human
to review your findings?
Any finding or assessment can be escalated by your team to a RelyAInt senior consultant — on demand, when you need it. Available on any plan — billed per engagement.
Fixed-price assessments from
$7,500
Full GAP assessments up to $25,000+
S T A R T H E R E
Ready to get inspection-ready?
Start with a free assessment on the compliance engine.
Your team can review findings, manage actions, and track progress — all within your portal.
No commitment required.
✓ No obligation ✓ Fully confidential ✓ Response within 48 hours ✓ Human governance built into every workflow