Pharma and Biotech Validation Services
​Ensuring Compliance
​Driving Quality
​Accelerating Innovation
At MAPTech Solutions, we specialize in providing expert validation consulting services to the pharmaceutical and biotechnology industries. Our team brings deep domain knowledge in GxP compliance, computer system validation (CSV), and equipment/facility qualification to support regulated environments across the drug development lifecycle.
Our Core Validation Services
1. Computer System Validation (CSV)
-
Validation planning, risk assessment, and protocol development
-
21 CFR Part 11 compliance (electronic records and signatures)
-
Data integrity assessments
-
Support for SaaS/cloud-based systems
-
Full lifecycle support from URS to decommissioning
2. Equipment and Facility Qualification
-
IQ/OQ/PQ protocol development and execution
-
Cleanroom validation
-
Environmental monitoring system qualification
-
Utility systems (HVAC, water, gases)
3.Quality and Compliance Consulting
-
Gap assessments and mock audits
-
SOP development and review
-
Training on validation best practices
-
Inspection readiness support
Why Choose MAPTech Solutions?
-
Deep Regulatory Expertise: Our consultants stay current with evolving FDA, EMA, and ICH guidance.
-
Scalable Support: Whether you need project-based support or long-term staffing, we flex to your needs.
-
Cross-Functional Experience: We work with QA, IT, engineering, and manufacturing to ensure holistic solutions.
-
Risk-Based Approach: Efficient, audit-ready validation rooted in science and compliance.
Who We Support
-
Pharmaceutical manufacturers (small molecule & biologics)
-
Biotech startups and emerging biopharma
-
CDMOs and CROs
-
Cell & gene therapy companies
-
Medical device and combination product firms
