OTC Drug Regulatory Expertise

We support companies developing, licensing, importing, or marketing over-the-counter (OTC) drug products in Canada and the United States. Our focus is regulatory defensibility—aligned with monographs, labelling requirements, and long-term compliance expectations.

Canada – Health Canada OTC Drugs

  • Product classification & pathway assessment
  • Monograph alignment (ingredients, indications, directions)
  • DIN readiness & submission support (as applicable)
  • Label compliance review (Drug Facts / Canadian requirements)
  • GMP / site licensing considerations (where required)
  • Post-market compliance & change management

USA – U.S. FDA OTC Framework

  • OTC monograph pathway guidance
  • Label & claims review (risk-focused, practical)
  • Facility & listing readiness direction (as applicable)
  • Regulatory documentation support for launch teams
  • Quality/compliance coordination with manufacturers
  • Change control support (formulation, claims, packaging)

What You Get

  • Clear pathway recommendation (what applies and what doesn’t)
  • Label/claims risk notes tied to requirements (not generic opinions)
  • Actionable next steps with timelines and responsibilities
  • Submission / readiness support where needed

Who We Work With

  • OTC brand owners & marketers
  • Contract manufacturers
  • Importers & distributors
  • International companies entering Canada/USA

Need clarity on your OTC regulatory pathway?

Book a confidential strategy call to confirm classification, monograph alignment, labelling requirements, and your fastest compliant path to market.

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