Regulatory Consulting
Strategic pharmaceutical consulting for companies navigating Health Canada regulations, GMP compliance, and market access.
CRO/CMO Advisory
Androxa provides strategic guidance for contract research organizations (CROs) and contract manufacturing organizations (CMOs) operating in the Canadian market. We help you establish compliant operations, prepare for Health Canada inspections, and optimize your regulatory processes.
Health Canada Regulatory Strategy
From pre-submission planning to post-market compliance, our consultants develop regulatory strategies tailored to your product type—whether pharmaceutical drugs, natural health products, medical devices, or combination products. We prepare complete submission dossiers designed for first-pass approval.
NHPD Licensing Support
Obtaining a Natural Product Number (NPN) from Health Canada's Natural and Non-prescription Health Products Directorate requires precise documentation. Androxa handles product classification, evidence compilation, monograph alignment, and the full NPN application process.
GMP Compliance & Audit Preparation
We perform comprehensive GMP gap assessments, develop remediation plans, create and review standard operating procedures (SOPs), and prepare your facility and team for Health Canada GMP inspections. Our approach ensures you're audit-ready—not just compliant on paper.
- GMP gap analysis and remediation planning
- SOP development and review
- Quality management system (QMS) implementation
- Mock audit and inspection preparation
- Corrective and preventive action (CAPA) programs