Inspection Readiness & Support
Preparation before inspections, practical support during regulatory activity and structured follow-up afterward.
Executive Quality & Regulatory Consulting
CliniQAl provides executive-level consulting to pharmaceutical, biotechnology and medical device organizations. We help clients prepare for inspections, strengthen quality systems and resolve complex quality and regulatory challenges across the product lifecycle.
WHEN EXPERIENCE MATTERS MOST
Organizations engage CliniQAl when independent expertise, practical judgment and executive quality leadership are needed most. Whether preparing for regulatory inspections, strengthening quality systems, leading remediation programs or navigating complex compliance challenges, CliniQAl delivers practical, risk-based solutions tailored to each client's needs.
Preparation before inspections, practical support during regulatory activity and structured follow-up afterward.
Design, implementation and continuous improvement of scalable quality systems supporting R&D through commercial operations across pharmaceutical, biotechnology and medical device organizations.
System, facility, vendor, investigator-site, laboratory and service-provider audits against applicable global requirements.
Quality systems, design control, safety vigilance, risk management, clinical compliance, supplier oversight and lifecycle support for medical devices and combination products.
Risk-based validation and compliance support for regulated clinical, manufacturing and laboratory systems.
Qualification, governance and performance oversight of critical suppliers, service providers and outsourcing partners.
Custom-designed training, workshops and certification programs across all GxP disciplines.
Systematic application of Quality Risk Management across all organizational levels and throughout the Quality Management System.
APPROACH
CliniQAl works closely with each client to understand the organization, its culture, and the regulatory and operational context behind every engagement. Solutions are tailored to the client's actual needs, with direct senior involvement from planning through delivery.
Let's keep it simple.
Experience
Providing independent, practical and risk-based quality and regulatory consulting across the full product lifecycle, helping organizations strengthen quality systems, navigate regulatory requirements and prepare confidently for inspections.
FOUNDER &
PRINCIPAL CONSULTANT
Arash Amirpour is the Founder and Principal Consultant of CliniQAl Consult Corporation. With over 25 years of international experience, he has supported pharmaceutical, biotechnology, medical device, combination product and clinical research organizations across all phases of product development and commercialization.
His expertise spans GxP quality systems, global regulatory compliance, inspection readiness, supplier qualification, clinical research, manufacturing, laboratory operations, and quality management systems. Throughout his career, he has partnered with organizations ranging from emerging biotechnology companies to global pharmaceutical manufacturers, providing independent, practical and risk-based consulting tailored to each client’s regulatory and operational environment.
Having worked globally, Arash brings a thoughtful, respectful and culturally aware approach to every engagement. He takes the time to understand each client’s organization, culture and unique challenges, fostering productive working relationships while maintaining the independence, objectivity and professional judgment essential to quality and regulatory consulting.
PROFESSIONAL CREDENTIALS
PREVIOUS INDUSTRY LEADERSHIP
Expertise
Practical expertise across products, disciplines, regulatory frameworks, and operating environments.
Product lifecycle
Support as products and quality systems mature from development through commercialization and post-market oversight.
Therapeutic experience
Clinical development and quality oversight across diverse therapeutic areas and product types.
Regulatory frameworks
Requirements applied according to the product, activity, and market.
Industries
Support for product companies and the partners, facilities, and research organizations behind regulated activities.
Located in Toronto, Ontario, Canada.
Supporting pharmaceutical, biotechnology, medical device and clinical research organizations worldwide.