Pharmaceutical Development Support
Regulatory guidance throughout the pharmaceutical development lifecycle—from early-stage planning to Health Canada market authorization.
Regulatory Pathway Planning
Androxa helps you identify the optimal regulatory pathway for your product. Whether you're developing a prescription drug, over-the-counter medication, or natural health product, we map out the Health Canada submission requirements, timelines, and evidence packages from day one.
NHP & Drug Submission Preparation
We prepare complete regulatory submissions including product licence applications, Drug Identification Number (DIN) requests, NPN applications, and Clinical Trial Applications (CTAs). Every dossier is assembled for first-pass approval with meticulous attention to Health Canada's evolving requirements.
Formulation & Stability Consulting
Our team advises on formulation optimization and stability study design that meets ICH and Health Canada guidelines. We review protocols, evaluate data packages, and ensure your stability program supports the shelf-life claims in your regulatory submission.
Post-Market Compliance
Once your product is on the market, Androxa helps you maintain compliance with Health Canada's post-market requirements including adverse event reporting, label updates, and periodic safety reports.
- Regulatory pathway assessment and strategy
- DIN, NPN, and CTA submission preparation
- Stability study design and data review
- Labelling compliance and Health Canada label reviews
- Post-market surveillance and reporting