Your Trusted Partner in Pharmaceutical & Biotech Quality Solutions
Axygen Pharmatech
Trusted partner in pharmaceutical & biotech quality solutions — auditing, training, consulting, and regulatory compliance.
About Axygen Pharmatech
Founded by Quality Assurance veterans with 75+ years of combined leadership in the pharmaceutical and biotech industries, AXYGEN PHARMATECH is a GxP Training, Auditing, Quality & Consulting company dedicated to delivering compliance-driven, practical, and forward-thinking solutions. We are now proudly part of the Fixity Group of Companies, enabling us to scale our global presence. We bring first-hand knowledge from global regulatory inspections (USFDA, EU-GMP, WHO), greenfield setups, and complex compliance challenges—translating that experience into measurable results for our clients.
Global Impact
Impact in Numbers.
A quick snapshot of Axygen Pharmatech across scale, focus, and impact.
Professionals Trained
Incident/Deviation Reduction
Regulatory Inspections Led
Facilities Served
Key Highlights
A quick snapshot of what sets Axygen Pharmatech apart.
Led multiple USFDA, EU and other regulatory inspections
Regulatory inspection leadership across USFDA, EU, and global audits with pre-inspection readiness, CAPA governance, and response strategy tailored for pharma and biotech operations.
Built quality systems for greenfield OSD, Injectables, API & Biotech facilities
Quality system architecture for greenfield OSD, Injectables, API, and Biotech facilities—from SOP structures and validation frameworks to risk controls and compliance-aligned execution.
Trained 10,000+ pharmaceutical professionals
Over 10,000 pharmaceutical professionals have been trained through role-based programs in GxP, GMP, and data integrity—designed to strengthen shop-floor execution, documentation quality, and audit preparedness.
Reduced incidents/deviations up to 40% via QMS improvements
QMS improvement initiatives that reduce incidents and deviations through root-cause discipline, process harmonization, and preventive controls integrated into day-to-day plant operations.
Enabled faster regulatory approvals and market readiness
Faster regulatory and market-readiness outcomes enabled through inspection-focused documentation, validation rigor, and quality-by-design execution across product lifecycles.
What We Offer
Core service offerings from Axygen Pharmatech.
Regulatory Readiness & Compliance Product-specific audits aligned to current guidelines with CAPA support, led by veterans with USFDA, EU-GMP, and WHO inspection experience. USFDA • EU-GMP • WHO
Our Products
Purpose-built solutions from Axygen Pharmatech.
LIMS
Laboratory Information Management
A laboratory information system that runs sample operations, master data, and lab workflows end to end — keeping testing structured, traceable, and audit-ready.
DMS
Document & Protocol Management
A document control system for SOP management, change control, and periodic review, ensuring every controlled document stays current, approved, and traceable.
TMS
Training Management System
Manage employees, assign training, and track completion across teams — connecting role requirements to documented competency.
QMS
Electronic Quality Management
Electronic quality management built around controlled documents and a workflow inbox, giving teams a single place to action quality events and approvals.
CPV + APQR
Process Verification & Annual Review
AI-powered OCR extraction from CoAs, control charts, and Cpk/Ppk indices, with one-click APQR PDF generation — turning batch data into continued process verification and annual product reviews.
AI Document Review
AI-Powered QA Document Review
OCR and AI extraction from batch records run an 18-point automated QA checklist, surfacing clear Approve/Reject batch decisions for faster, more consistent review.
AI Quality Dashboard
AI-Driven Quality Metrics (QMD Pro)
Track batch acceptance, OOS rates, complaint ppm, CAPA effectiveness, lab errors, and APR compliance across 7 live KPIs in one quality-metrics view.
Pharma Lens
GMP Workforce Competency
An expert-led GMP training library with AI-scored competency tests, CIP curriculum paths, and digital certificates — building and proving workforce competency.
Ready to Transform?
Contact us today to explore how Axygen Pharmatech can empower your organization.