OUR SERVICES
Streamline Quality Systems
Achieve Regulatory Compliance
Bring Safe, Effective Products to Market
Quality Management Systems (QMS) Development & Implementation
What We Do:
Design, implement and maintain a phase-appropriate QMS for compliance with FDA, ISO and EU requirements as appropriate.
Develop risk-based approaches to enhance quality and efficiency.
Establish robust documentation practices, SOPs, and quality processes.
Who Benefits:
Pharmaceutical Companies: Streamlining processes and ensuring regulatory compliance.
Medical Device Manufacturers (including In vitro diagnostics): Establishing compliant QMS for product development and commercialization.
Biotech and Life Sciences Startups: Building quality foundations from the ground up.
Natural Health Product Companies: Meeting regulatory requirements for supplements and nutraceuticals.
Regulatory Affairs & Compliance Consulting
What We Do:
Guide companies through regulatory submissions to FDA and Health Canada.
Develop regulatory strategies, including breakthrough device designations.
Prepare for and support regulatory inspections, including documentation and audit readiness.
Who Benefits:
Pharmaceutical Companies: Ensuring compliance in drug development and manufacturing.
Medical Device Manufacturers (including In vitro diagnostics) : Navigating complex device regulations and achieving market approval.
Quality Assurance Auditing & Inspection Readiness
What We Do:
Conduct internal and supplier quality audits as a certified Quality Auditor (ASQ CQA).
Perform gap assessments and develop corrective and preventive action (CAPA) plans.
Prepare teams for successful regulatory and client inspections.
Who Benefits:
Pharmaceutical Companies: Strengthening internal compliance and inspection preparedness.
Medical Device Manufacturers (including IVDs): Performing supplier audits and enhancing internal quality audit programs.
Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs): Enhancing audit readiness and compliance.
Biotech Startups: Building robust audit practices early in development.
Analytical Chemistry Data Review Services
What We Do:
Perform in-depth review of analytical testing results including method validation, stability studies, and product release.
Develop analytical strategy and support early-stage startups with technical guidance.
Who Benefits:
Pharmaceutical Companies: Ensuring compliance while guaranteeing the accuracy and reliability of reportable results.
Biotech and Life Sciences Startups: Supporting method development and analytical strategy.
Diagnostic and In Vitro Device Companies: Providing expertise in assay validation and data integrity.
Risk Management & Product Development Support
What We Do:
Develop risk management plans following ISO 14971 for medical devices and diagnostics.
Support clinical trial protocol development and product safety evaluations.
Collaborate on Target Product Profiles (TPP) with industry experts.
Who Benefits:
Pharmaceutical Companies: Implementing risk management strategies across product lifecycles.
Medical Device Manufacturers: Mitigating risks throughout product development.
Diagnostic and In Vitro Device Companies: Preparing for clinical validation and regulatory submissions.
Biotech Startups: Identifying and managing risks early in the development cycle.
Customized Solutions for Startups and SMEs
What We Do:
Offer tailored consulting packages, including virtual quality support and fractional QA leadership.
Develop strategic roadmaps for startups to achieve regulatory compliance and quality excellence.
Provide mentorship and guidance on building sustainable quality practices.
Who Benefits:
Biotech and Life Sciences Startups: Accessing quality expertise without full-time overhead.
Small to Medium Enterprises (SMEs) in Life Sciences: Scaling quality systems as the business grows.
Innovation Hubs and Incubators: Providing resident startups with access to quality and regulatory expertise.
What We Do:
Offer customized training on GMP, quality systems, risk management, and design controls.
Develop and deliver audit and inspection readiness training and regulatory compliance workshops.
Provide professional education through academic institutions and corporate programs.
GMP Training & Education
Who Benefits:
Pharmaceutical and Medical Device Companies: Preparing teams for regulatory compliance and inspections.
Educational Institutions and Training Providers: Enhancing curriculum with industry insights.
CROs & CMOs: Building internal training programs for staff development.
Natural Health Product Companies: Ensuring teams understand relevant quality standards.
TESTIMONIALS
“It is my pleasure to recommend Dr. Azeret Zuniga. I’ve known Azeret for 10 years, starting at Gilead where I worked with her for analytical QA approvals and GMP investigations for an early-phase project.
Our collaboration at Gilead was so successful, I recently reached out to her again to help with DS and DP analytical data review. I knew we could work well together and she would do a thorough job as her time at Gilead provided her a solid background in working with CDMOs, GMP requirements, and ingrained in her a high bar for compliance and attention to detail. I also knew she wouldn’t be a push over and will stand her ground, but with an understanding of the science, project phase and regulations/guidelines, the appropriate risk-tolerance would be applied.
Azeret is smart, hard-working, and dedicated who works well in a team-environment or independently, with diverse experience in drug substance, natural products, medical devices, and is currently working with drug product. She has experience in analytical development, QC, QA and regulatory with early, late-phase and commercial projects and has managed or led departments. She would be a great asset to any company.”
Mark Davis, Sr. Director Analytical Chemistry