PHARMA AND BIOTECH VALIDATION, DONE RIGHT.

Ensuring Compliance. Driving Quality. Accelerating Innovation.

ABOUT

MAPTech Solutions specializes in validation consulting for pharma and biotech — GxP compliance, CSV, CSA, equipment/facility qualification across the drug development lifecycle. We work as an extension of your team.

Core Services

Computer System Validation & CSA

Deep expertise in planning, risk assessment, and protocol development. Navigating 21 CFR Part 11 for SaaS, cloud, and COTS from initial URS through decommissioning.

Learn More

Equipment & Facility Qualification

Comprehensive IQ/OQ/PQ services. Specialized in cleanroom validation, environmental monitoring systems, and critical utilities for pharma and biotech facilities.

Learn More

Compliance Consulting

Gap assessments, mock audits, and SOP development. We prepare your team for inspection readiness under Part 11, Annex 11, and the latest global standards.

Learn More

Data Integrity

ALCOA+ assessments, comprehensive DI policies, and data governance programs. Protecting the integrity and reliability of clinical and manufacturing records.

Learn More

Who We Support

Pharma Manufacturers / Biotech Startups / CDMO / CRO / Cell & Gene Therapy / Medical Device

Why Choose MAPTech Solutions

We bridge the gap between technical infrastructure and global regulatory expectations with a precision-engineered approach to validation.

REGULATORY

Regulatory Leadership

We stay current on all global regulations, including FDA CSA (Sept 2025), GAMP 5 Second Edition (2022), and the upcoming EU Annex 11 revision (2026).

METHODOLOGY

Risk-Based Approach

Moving beyond checkbox compliance, we apply critical thinking to focus efforts where quality and patient safety are most at risk, optimizing total project value.

ENGAGEMENT

Scalable Engagements

Whether you are a biotech startup or a global pharma manufacturer, our team integrates seamlessly to provide flexible support across the drug development lifecycle.

EXPERTISE

Cross-Functional Team

Our experts bridge engineering, QA, and IT. We understand the technical nuances of SaaS, cloud infrastructure, and facility utilities as well as the compliance requirements.