Pharma validation
experts engineering
regulatory excellence.
Qualify IT Solutions is a leading pharmaceutical validation and compliance partner, delivering world-class CSV, CQV and GxP solutions for regulatory excellence and operational efficiency.
Built by engineers, for regulated industries.
Qualify IT Solutions is a startup company in engineering & design, having successfully executed CSV and CQV projects across Infrastructure, Pharmaceutical, Biotechnology and Software industries.
Our team of CSV & CQV engineers is skilled at taking your project from concept to operation, providing local support backed by global subject matter expertise.
We deliver cost-effective designs that meet regulatory requirements — covering validation of process equipment, utilities, control systems and facilities, both GxP and non-GxP.
50+
Projects Delivered
15+
Enterprise Clients
100+
Compliance Track
ISO 9001:2015
Certified Quality Management
Our Mission
To deliver regulatory-grade engineering, validation and software that empowers life-sciences companies to manufacture safely, compliantly and efficiently.
Our Vision
To be the most trusted CSV, CQV and GxP partner for emerging and established pharma & biotech manufacturers worldwide.
Principles that guide every
engagement
The commitments behind our pharmaceutical excellence and client success.
Quality Excellence
Uncompromising standards across every validation, qualification and engineering deliverable.
Regulatory Compliance
Built around GxP, GAMP 5, EU Annex 11 and 21 CFR Part 11 from day one.
Innovation
Modern, risk-based approaches and Kośa GxP software that simplify compliance.
Client Satisfaction
Long-term partnerships built on transparency, ownership and on-time delivery.
Specialized solutions across
life sciences
Pharmaceutical
Manufacturing facilities, QC systems and regulatory compliance solutions.
Biotechnology
Biotech facilities, research systems and specialized equipment validation.
Infrastructure
Facility design, utilities validation and infrastructure commissioning.
Software
Application validation, system integration and software compliance.
Comprehensive validation &
compliance services
Spanning the full lifecycle — from URS and risk assessment to qualification, ongoing compliance and digital quality systems.
Computer System Validation (CSV)
Excel Sheet Validation
GAMP 5 Guidelines Implementation
Risk-Based Validation Strategies
Commissioning & Qualification (CQV)
Pharmaceutical Training Programs
21 CFR Part 11 Compliance
Data Integrity Solutions
The people behind your
compliance
A multi-disciplinary team of engineers, auditors and software builders dedicated to regulated industries.
Leadership Team
Founders & Directors
20+ years of combined experience in CSV, CQV and pharmaceutical engineering across global markets.
Validation Engineers
CSV & CQV Specialists
Certified engineers delivering validation lifecycle support — from URS to PQ and ongoing compliance.
Quality & Compliance
GxP Subject Matter Experts
Auditors and SMEs ensuring every deliverable meets GAMP 5, 21 CFR Part 11 and EU Annex 11.
Software & Kośa Team
GxP Software Engineers
Builders behind Kośa DMS & LMS — purpose-built, validated software for life-sciences operations.
Trusted by leading pharma
biotech
We’re proud to partner with innovators across India, Europe and beyond.
Virchow Biotech Pvt Ltd
Units 1, 2, 4, 5
GCBC Vaccines Pvt Ltd
Medchal, MuppireddyPalli
Inter Chemie werken "De Adelaar" B.V.
Netherlands
Bharat Biotech
Turkapally
SVVS Cal Labs Pvt Ltd
Pragathi Nagar
Aurobindo Pharma
Hyderabad
Ready to partner with us?
Let’s discuss how our expertise can help your pharmaceutical operations achieve regulatory excellence and operational efficiency.