Our Mission
At QualReg Solutions, our mission is to empower regulated industries with expert regulatory guidance, ensuring compliance with FDA regulations and international standards. We are committed to providing innovative, effective, and risk-based solutions to help our clients navigate complex compliance landscapes, improve product quality, and achieve sustainable business success.
Integrity & Compliance
We uphold the highest ethical and regulatory standards, ensuring our clients operate within full compliance of applicable FDA regulations and ISO principles.
Our Values
Risk-Based Approach
We apply a risk management framework to help clients proactively identify, assess, and mitigate regulatory risks.
Innovation & Continuous Improvement
We embrace data-driven decision-making, leveraging technology and best practices to improve regulatory efficiency and business performance.
Customer Focus
We prioritize our clients' success by providing tailored compliance strategies that meet their unique business needs.
Quality Excellence
We strive for continuous improvement, ensuring that all processes, systems, and services align with the best industry practices and quality management system (QMS) requirements.
Collaboration & Knowledge Sharing
We work closely with clients, regulatory bodies, and industry stakeholders to promote compliance awareness and best practices.
QualReg Solutions is committed to delivering high-quality regulatory consulting services that align with applicable ISO principles and FDA Good Manufacturing Practices (GMPs). Our quality management objectives include:
Our Quality Policy
Compliance Assurance
Ensuring all clients meet applicable FDA regulations (21 CFR) and international standards such as ISO 13485 and ISO 17025.
Process Efficiency
Standardizing and validating quality system processes to enhance efficiency and reliability.
Customer Satisfaction
Continuously improving our services to exceed client expectations through feedback-driven enhancements.
Competency & Training
Ensuring that our team and clients are equipped with up-to-date regulatory knowledge, including structured training programs and continuous learning.
Risk Management
Implementing a risk-based approach to compliance, reducing regulatory burdens while maintaining high product safety and quality.
Our Team
Gabriel Muñiz
Principal & Founder