Over-the-Counter (OTC) Drug Submission

OTC products sit at a difficult intersection: they must satisfy drug‑level standards while moving at consumer‑product speed. We structure over‑the‑counter submissions so they align cleanly with applicable monographs or non‑monograph pathways in Canada and the USA.

Our work starts with classification. We confirm whether your active ingredients, strengths, dosage forms, and claims truly fit within OTC frameworks, then outline the corresponding data, labelling, and quality requirements. From there, we assemble application packages, coordinate any necessary testing through qualified laboratories, and align carton, label, and insert text with regulatory expectations.

Before filing, we review the dossier for internal consistency and clarity, focusing on the points regulators most often question, such as directions for use, warnings, and child‑safety considerations. Throughout the process, we keep communication structured and timelines transparent so your commercial, quality, and regulatory teams can plan launches with confidence, knowing that compliance risks have been tightly managed up front.