Compliance Consulting

Global regulations keep evolving - every year they’re released by the thousands, and for any organization, staying compliant is costly and complicated.

Navikenz’s Compliance Consulting offerings are aimed to keep you updated and on track with all in-force regulations. Our operating model helps you comply with industry standards, while our quality and technology experts help with independent validation services and systems that support regulatory functions. Our best practices focus on FDA and other regulatory authority guidelines on computer system validation, electronic records and signatures, and information security management

Validation Transformation

Embrace the future of compliance with our cutting-edge technology solutions. With our compliance-focused approach, you'll not only meet current regulatory requirements but also stay ahead of the curve in a rapidly evolving landscape.  From AI-powered compliance monitoring systems to data integrity platforms, we harness the latest innovations to streamline processes, enhance transparency, and future-proof your compliance efforts.

Independent validation services

Ensuring timely and efficient computer systems compliance, tuned to the regulatory requirements applicable.

Application development and maintenance

Our services are fully compliant with FDA guidelines and global quality standards while leveraging the latest technical solutions available, helping you quickly adapt to changing business conditions

Specialized consulting

Includes the evaluation of off-the-shelf products for 21 CFR Part 11, Part 210-211 compliance, working with the business process reengineering framework and evaluating the impact of global regulatory updates