EXPERT COMPLIANCE AND QUALITY MANAGEMENT FOR THE LIFE SCIENCES INDUSTRY
PHASE- APPROPRIATE SUPPORT FROM A CERTIFIED QUALITY AUDITOR AND COMPLIANCE CONSULTANT
I’m Azeret Zuniga, Principal Consultant at AZM Compliance Solutions. I specialize in guiding life sciences companies through complex regulatory and quality system challenges. With over a decade of experience in pharmaceuticals, medical devices, and natural health products, I help businesses achieve compliance excellence, streamline quality management systems, and bring safe, effective products to market. My goal is to provide strategic, phase-appropriate support that not only meets regulatory requirements but also drives operational efficiency and product quality. I'd love to learn more about your quality and compliance needs and explore how I can support your business goals.
OUR SERVICES INCLUDE:
Quality Management Systems (QMS) Development & Implementation
Transform your organisation's efficiency and compliance with our innovative Quality Management Systems (QMS) Development & Implementation services, designed to elevate your standards and drive continuous improvement.
Regulatory Affairs & Compliance Consulting
Unlock your organization’s potential with our specialized Regulatory Affairs consulting services. Navigate compliance complexities while enhancing operational excellence and efficiency. Obtain a regulatory strategy that aligns with your goals and accelerate time to market.
Quality Assurance Auditing & Inspection Readiness
We help you identify compliance gaps, strengthen quality systems, and prepare with confidence for regulatory inspections. We conduct comprehensive internal audits, mock inspections, and risk assessments to ensure your operations align with current GMP, ISO, and other applicable standards. Stay audit-ready—minimize risk, enhance compliance, and safeguard product integrity.
Analytical Chemistry Data Review Services
Obtain peace of mind that your analytical testing results are correct, complete and compliant. Ensure data integrity, regulatory compliance, and scientific accuracy across all stages of product development-from preclinical studies to commercial release
Risk Management & Product Development Support
Elevate your organization’s compliance and efficiency with our cutting-edge risk management and product development support, focusing on compliance and fostering continuous improvement.
Customized Solutions for Startups and SMEs
Unlock the potential of your startup or SME with our tailored Quality Management System (QMS) development and implementation services, tailored to the size of your organization and the phase of the program.
GMP Training & Education
GMP training and education empowers your organization to enhance efficiency and builds a strong quality culture. Our training is aimed at uplifting your standards and fostering ongoing improvement
ABOUT AZERET ZUNIGA: CERTIFIED QUALITY AUDITOR AND CONSULTANT
Azeret Zuniga is a seasoned Quality Assurance (QA) leader with over a decade of experience in the pharmaceuticals, medical device, and natural health products industries. As the Principal Consultant at AZM Compliance Solutions, Azeret is dedicated to providing strategic and phase-appropriate support to life sciences companies, helping them navigate complex regulatory landscapes and achieve compliance excellence.
With a Ph.D. in Analytical Chemistry from the University of Alberta, Azeret brings a robust scientific background to her consulting practice. She offers specialized consulting services, including quality management system (QMS) development and implementation, regulatory compliance, internal and external audits, risk management, GMP training, and analytical data review for stability studies, method validation, and product release. She is a certified Quality Auditor (ASQ CQA) and holds a Regulatory Affairs Certification (RAC) in Medical Devices.
LEADING COMPLIANCE INITIATIVES AND EDUCATING FUTURE QUALITY EXPERTS
A CAREER BUILT ON EXCELLENCE AND KNOWLEDGE SHARING
Azeret's career spans pivotal roles at large multinational, mid size and dynamic start-up companies where she led cross-functional teams, managed compliance with FDA, ISO 13485, and EU IVDR standards, and contributed to successful regulatory submissions.
Beyond consulting, Azeret shares her knowledge as an instructor in the Quality Management Certification Program at the Northern Alberta Institute of Technology (NAIT), educating the next generation of quality professionals on topics such as documentation, auditing, statistical process controls, and quality assurance best practices.
Fluent in English and Spanish, Azeret is committed to driving quality and compliance solutions that support safe, effective, and high-quality products in global markets.
Azeret Zuniga Morales
Ph.D. Certified Quality Auditor (ASQ CQA), RAC (Medical Devices)
Principal Consultant | AZM Compliance Solutions
