⚠ REGULATORY ALERT FDA Warning Letters up 34% in 2025 — Is your validation documentation audit-ready? Get a Free Gap Assessment →
FDA · GxP · ISO · GDPR · NIST

An FDA inspection
shouldn't be your
first audit.

Expert computer system validation and regulatory compliance consulting for pharmaceutical, biotech, and medical device companies — globally, affordably, and without compromise.

FDA 21 CFR Part 11
GxP Validation
ISO 42001 AI Compliance
Risk-Based Approach
GDPR & Data Privacy
NIST AI RMF
Start Your Project Reg Library →
📋
Computer System Validation
FDA 21 CFR Part 11 · GAMP 5 · CSV/CSA
✅
GxP Qualification
IQ · OQ · PQ · DQ · Equipment Validation
🤖
AI Compliance (HIL)
ISO 42001 · NIST AI RMF · Human-in-Loop
🔍
Regulatory Auditing
Gap Analysis · Mock FDA Audits · CAPA
Pharmaceutical Compliance
Biotech Validation
Medical Device Quality
Clinical Trials Data Integrity
AI Systems Governance
Global Regulatory Support
// the cost of non-compliance

The price of an FDA
Warning Letter.

Non-compliance isn't just a regulatory problem. It's a business-ending event.

⛔
Import Alerts
FDA can block all products from your facility from entering the US market — immediately, without warning.
Average Revenue Loss
$2M–$50M+
⚖️
Consent Decrees
Forced shutdown of manufacturing operations, third-party oversight, and years of remediation at your expense.
Remediation Cost
$100M+
📉
Reputational Damage
Warning Letters are public. Customers, partners, and investors see every citation — and they act accordingly.
Market Cap Impact
Irreversible
// core services

What we deliver.

End-to-end compliance consulting — from initial gap analysis through audit readiness and ongoing monitoring.

01
🖥️
Computer System Validation

Full CSV lifecycle from URS through VSR. GAMP 5 methodology, FDA 21 CFR Part 11 compliant, risk-based approach for all GxP systems.

21 CFR Part 11GAMP 5URS/FRSIQ/OQ/PQ
02
⚗️
Equipment Qualification

DQ, IQ, OQ, and PQ for manufacturing and laboratory equipment aligned with FDA, EMA, and ICH Q guidelines.

DQ/IQ/OQ/PQICH Q10FDA/EMAGMP
03
🔍
Regulatory Gap Analysis

Comprehensive assessment against applicable regulations. Identify deficiencies, prioritize remediation, build a structured compliance roadmap.

Gap AssessmentRisk MappingCAPARoadmap
04
📁
Documentation & SOPs

Author, review, and remediate SOPs, Validation Protocols, and Master Plans with full audit trail compliance.

SOPsValidation PlansAudit Traile-Signatures
05
🛡️
Mock FDA Audits

Simulate FDA inspections using current protocols. Identify vulnerabilities before regulators do.

FDA 483Warning LettersInspection PrepResponse Plans
06
📊
Data Integrity & Annex 11

ALCOA+ principles across all critical data systems. EU GMP Annex 11 and FDA Data Integrity guidance compliant.

ALCOA+Annex 11Data GovernanceAudit Trails
// our methodology

Compliance as a
strategic asset.

Our 7-step framework transforms regulatory requirements into operational strength.

01
Regulatory Mapping
Identify all applicable regulations for your industry, product, and geography.
02
Gap Analysis
Evaluate current policies against required standards. Quantify deficiencies.
03
Policy Development
Draft written procedures, appoint compliance leadership, establish training structures.
04
Technology Implementation
Deploy compliant LMS, document control, and RegTech tools with full audit trails.
05
Culture Embedding
Make compliance everyone's responsibility through training and accountability frameworks.
06
Continuous Monitoring
Ongoing internal audits, risk reassessments, and regulatory update tracking.
07
Audit Readiness
Full documentation, secure storage, instant retrieval for any regulator.
// regulations we cover
FDA 21 CFR
Part 11 · Part 210/211 · Part 820
GAMP 5
Computer System Validation
EU GMP
Annex 11 · Annex 15 · Annex 21
ICH Q10
Pharmaceutical Quality System
ISO 13485
Medical Device Quality
HIPAA
Health Information Privacy
GDPR
EU Data Protection Regulation
ISO 42001
AI Management Systems
NIST AI RMF
AI Risk Management Framework
SOX
Financial Controls & Reporting
// industries served

Built for regulated industries.

Every industry faces a different regulatory landscape. We know yours.

💊
Pharmaceutical
FDA · EMA · ICH
GMP · GDP · GLP
21 CFR 210/211
🧬
Biotech
FDA BLA/IND
GCP · GAMP 5
Data Integrity
🏥
Medical Device
FDA 510k/PMA
ISO 13485 · MDR
21 CFR Part 820
🔬
Clinical Research
GCP · ICH E6
21 CFR Part 11
CTMS Validation
// AI compliance consulting

AI governance with
humans in the loop.

Structured AI governance frameworks that satisfy regulators while preserving the benefits of automation.

Discuss AI Compliance
🤖
ISO 42001 Implementation
Build and certify an AI Management System satisfying the world's first international AI standard.
⚖️
Human-in-the-Loop (HIL) Design
Design oversight workflows where human review gates AI outputs at critical decision points.
📐
NIST AI RMF Alignment
Map your AI systems against the NIST AI Risk Management Framework — Govern, Map, Measure, Manage.
🔐
AI Validation for GxP Systems
Validate AI/ML components within GxP systems aligned with emerging FDA guidance.
// get started

Don't wait for a
483 to find out.

Tell us about your project. We'll respond within 24 hours with a tailored proposal — no obligation, no boilerplate. Most clients are audit-ready within 90 days.

// regulatory intelligence

Global compliance library.

Structured regulatory breakdowns, implementation guidance, validation expectations, and data integrity requirements across FDA, EU, ISO, AI governance, and global privacy frameworks.

// validation artifacts

Validation document templates.

Download structured CSV and CSA templates aligned with FDA, GAMP 5, Annex 11, and modern risk-based validation practices. Free with registration.

📥

Download Template

Enter your information below to access this free validation document template.

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