PHARMACEUTICAL CONSULTING
Where Validation Excellence Meets Intelligent Innovation
AzulGreen delivers scalable, audit-ready CQV programs and AI-powered digital transformation for the pharmaceutical and biopharma industries — built on 22 years of hands-on GMP expertise.
22+
YEARS GMP EXPERIENCE
Director
LEVEL EXPERTISE
SCALABLE CQV PROGRAMS
AI ENGINEERING
Pharma 4.0
AI & DIGITALIZATION
DATA INTEGRITY
REGULATORY INSPECTION READINESS
Prevalix — AI-powered compliance documentation for life sciences
The compliance documentation platform built by QA practitioners, for QA practitioners.
Prevalix is an AI-powered platform that helps pharma, biopharma, and medical device teams draft and review compliance documentation in a fraction of the time. Built on 22+ years of GMP, validation, and data integrity experience, Prevalix generates draft content grounded in your organization's own knowledge base, so your QA, validation, and engineering teams spend less time authoring and more time on the work that matters.
One platform. Every document your quality team touches:
RAG Assistant — Instant, document-grounded answers to GMP and regulatory questions
SOP Drafter — Drafts complete, formatted SOPs in minutes
URS Drafter — Generates User Requirement Specifications with built-in CPP/CQA libraries
Deviation Assistant — Guided 5-step deviation workflow from initiation to closure
Review Agent — Gap analysis and intelligent re-drafting against your standards
CAPA Drafter — Drafts corrective and preventive action records, standalone or from a deviation
Change Control — Drafts change control records with IA, implementation plan, and effectiveness verification
Periodic Review — Generates periodic review documentation for systems and processes
Risk Management — Risk Assessments, FMEAs, and SRAs with table generation and export
Quiz Generator — Builds training quizzes directly from your SOPs
Comprehensive Validation & Compliance Services
We manage and drive your validation efforts so your team stays focused on core business deliverables. Clean execution, clear documentation, every time.
Facilities, Utilities & Equipment (FUE) Qualification
Commissioning and qualification programs for new facility startups, expansions, and equipment lifecycle management built for regulatory scrutiny.
AI Engineering & Pharma 4.0 Digitalization
End-to-end digital transformation strategy from maturity assessments to SCADA/MES/LIMS integration readiness — grounded in ISPE and ICH Q9 frameworks.
Process Validation & Cleaning Validation
Process Performance Qualification (PPQ), cleaning validation, and shipping validation programs designed to hold up under the toughest regulatory inspections. Our risk-based approach ensures validation protocols are scientifically sound, audit-ready, and aligned with current FDA and ICH Q7 expectations — from protocol authoring through final report approval.
Computer System Validation (CSV) / CSA
Risk-based CSV and Computer Software Assurance programs aligned with current FDA expectations, GAMP 5, and 21 CFR Part 11 requirements.
Data Integrity & Gap Assessments
Comprehensive data integrity risk assessments and remediation plans. FDA 483 response and warning letter support from a consultant who has defended programs firsthand.
The Difference Is in the Execution
AzulGreen was founded on a simple conviction: excellent validation doesn't require a large team — it requires the right expertise. As a former Director of QA Validation & Data Integrity, our principal has successfully defended CQV programs through multiple regulatory inspections.
Let’s Talk About Your Program
Whether you need a full CQV program build, an AI digitalization roadmap, or a rapid gap assessment — we'd like to hear about your challenge.