Quality assurance and regulatory consulting
Quality assurance & regulatory support you can rely on
Navigating regulatory requirements and maintaining GMP compliance can quickly become overwhelming. Evolving guidelines, complex submission pathways, and inspection pressures can slow progress, increase risk, and impact your ability to bring products to market on time. Our Toronto team of experts provide integrated Quality Assurance and Regulatory consulting services designed to keep your operations compliant, efficient, and audit-ready—at every stage of the product lifecycle.
Regulatory clarity. Operational confidence. Trusted expertise.
Our experienced team supports pharmaceutical, biopharmaceutical, OTC, Natural Health Product (NHP), medical device, and cosmetic companies with practical, compliant solutions tailored to your program needs. We bring in-depth knowledge of Health Canada, FDA, and EMA frameworks to help you confidently navigate global regulatory expectations.
Stay compliant in a complex regulatory landscape In Canada, multiple regulatory bodies—including NNHPD, PDD, and VDD—oversee product approvals and compliance requirements.
We help you interpret and meet these requirements efficiently, ensuring your products align with safety, efficacy, and quality standards.
End-to-end regulatory and QA support
Comprehensive services that align your quality systems with regulatory expectations and support your operational goals:
Regulatory services
- Drug Establishment Licenses (DEL): applications, renewals, and site additions
- Product classification and licensing (DIN, NPN, NDS, ANDS)
- Adverse reaction reporting and pharmacovigilance
- Nitrosamine risk assessments and regulatory compliance support
- Veterinary Health Product (VHP) notifications
Quality assurance & QMS
- SOP development and lifecycle management
- Product release and QA oversight
- Complaint handling, deviation management, and recall support
- CAPA development and implementation
Audit & inspection readiness
- GMP site audits and gap assessments
- Inspection readiness and on-site QA support
- Rapid response to regulatory observations
Training & operational support
- GMP and regulatory training programs
- SOP and compliance training for teams
- Warehouse GMP training and qualification services
Labelling, stability & lifecycle support
- Label creation and compliance review (including bilingual requirements)
- Stability program design and data evaluation
- Retain sample storage and management aligned with GMP
A partner that simplifies complexity
You need more than guidance—you need a partner who can anticipate challenges, streamline processes, and keep your program moving forward.
Our team works alongside you to:
- Reduce regulatory risk and avoid costly delays
- Strengthen your quality systems and inspection readiness
- Ensure accurate, compliant documentation
- Support lifecycle management from development to post-market
Get in touch
With a deep understanding of regulatory expectations and GMP requirements, we facilitate your journey in ensuring compliance, inspection-ready, and confident in every decision.