For Ongoing Regulatory Support
Many emerging companies don’t need a full-time Regulatory Affairs team—just the right senior counsel a few hours a week. Oak LS provides fractional leadership led by former Health Canada–experienced directors who embed with your team to keep filings moving, risks low, and decisions clear.
Weekly touchpoints and rapid responses on classification, claims, labels, and changes (NHP/DIN/device/food/VHP).
Plan and run Health Canada touchpoints (pre-sub, Clarimails/IRNs, NoDs), track commitments, and maintain clean correspondence.
Roadmap for CTAs/DINs/NHPs, amendments, notifications, post-market changes, and renewals—no surprises.
SOP/QMS oversight, label/advertising review, PV for self-care (AE capture, signals), and audit prep.
Centralized vs local REB strategy, submissions, continuing review.
Monitor guidance/policy changes and translate them into concrete actions for your portfolio.
Targeted briefings for execs, product, medical, and commercial teams; playbooks and templates.
Outcome: senior-level regulatory direction without full-time overhead—steady progress, cleaner reviews, and an inspection-ready organization.
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