ITGxP delivers enterprise-grade IT managed services and regulatory-ready GxP solutions for life sciences, pharmaceuticals, healthcare, and beyond — audit-defensible and AI-powered.
Struggling with validation delays, compliance gaps, offshore risks, or rising IT costs? We provide structured, AI-enhanced managed services — without compromising regulatory integrity.
Full-stack IT operations from L1 service desk to L3 architecture, aligned with your business SLAs and growth plans.
Deep expertise in FDA, EMA, GAMP 5, 21 CFR Part 11, and Annex 11 requirements for regulated industries worldwide.
Every URS, IQ/OQ/PQ, traceability matrix, and validation report crafted to withstand the strictest regulatory scrutiny.
Intelligent ticket triage, predictive monitoring, and automated diagnostics accelerate every workflow and reduce MTTR.
Structured offshore teams deliver 30–50% cost reduction without sacrificing quality, security, or compliance controls.
VPN-protected environments, role-based access, audit logs, and US-based governance for end-to-end delivery security.
End-to-end technology and compliance services built to scale with your organization and protect your regulatory standing.
Scalable, performance-driven IT operations covering application support, cloud infrastructure, AI automation, and digital transformation initiatives.
Inspection-ready, risk-based Computer System Validation and compliance services aligned with FDA, EMA, and global regulatory frameworks.
Cost-efficient offshore delivery backed by US-based oversight, secure infrastructure, and structured SLA-driven governance frameworks.
From CSV documentation to data integrity assessments — every service designed for inspection readiness.
Validation Plans & Strategy Development
User Requirement Specifications (URS)
Functional Requirement Specifications (FRS)
IQ / OQ / PQ Protocol Authoring
GAMP 5 Risk Assessments
Traceability Matrix (RTM)
Validation Summary Reports
Change Control Impact Assessments
Electronic Records Assessment
Audit Trail Review & Configuration
Access Control Evaluation
Data Integrity Gap Assessment
System Compliance Remediation
Annex 11 Readiness Reviews
LMS Implementation & Validation
EDMS Validation
LIMS Validation
CAPA & Deviation Systems
Change Control Management
SOP Development & Implementation
Integration Validation
ALCOA+ Assessments
Mock Audits & Inspection Simulation
Documentation Remediation
GDP Training Programs
Regulatory Risk Mitigation
Inspection Readiness Preparation
A structured, transparent process from discovery to continuous delivery — every step governed and documented.
Audit systems, gaps, and technology landscape
Custom plan with risk-based prioritization
Secure, governed offshore + US oversight
Full docs, testing, and audit-trail management
24/7 monitoring and lifecycle governance
Our offshore model combines skilled delivery teams in India with US-based governance and security controls — giving you the best of both worlds.
From FDA-regulated life sciences to enterprise technology, ITGxP brings domain-specific expertise to every engagement.
What our clients say about working with ITGxP across IT managed services and GxP compliance engagements.
"ITGxP transformed our CSV validation process. Their GAMP 5-aligned documentation was inspection-ready from day one, and the offshore team was indistinguishable from an onsite team."
"The 30% cost savings through their offshore model were real — and the US governance framework gave us full confidence in compliance. An exceptional partner for regulated IT."
"From 21 CFR Part 11 assessments to full LIMS validation, ITGxP delivered on every commitment. Their audit-ready documentation saved us weeks during our FDA inspection prep."
Founded under KBHPS Info Tech Pvt Ltd, ITGxP bridges enterprise IT innovation with GxP regulatory precision — helping organizations scale confidently while maintaining compliance integrity.
Honesty and transparency in every client engagement and deliverable.
Meticulous attention to regulatory requirements and documentation standards.
Full ownership of outcomes at every stage of the delivery lifecycle.
Leveraging AI and modern frameworks to push performance boundaries.
Long-term relationships built on trust, measurable results, and shared goals.
Let's build your next compliant, scalable digital ecosystem together. Our experts are ready to assess your environment and design a solution that works.
Contact ITGxP Today →Whether you need IT managed services, GxP compliance expertise, or an offshore delivery partner — we're ready to help you succeed.
info@itgxp.com
Lowell, Massachusetts 01876
SY No 142, Villa 3, Royal Village Sai Nagar
Pragathinagar, Qutbullapur — 500004