Confidence Beyond Compliance

Switching a medicinal product from prescription-only (Rx) to over-the-counter (OTC) can be an attractive option, both for patients and manufacturers. It isn’t a simple process however. It is important to carefully consider which path to take for an Rx-to-OTC switch, as a negative decision means resolving a legal dispute regarding the amount of national freedom that ultimately remains. We advise medicinal product manufacturers in strategic planning and implementation so that their Rx-to-OTC switches succeed every time.

PharmaLex is a worldwide leader in drug safety, with more than 30 years in pharmaceutical consulting services, including a decade of experience helping companies switch Rx products to OTC. We have worked with clients to evaluate and develop Rx-to-OTC switch applications in areas such as Eye Care, Sleep Aids, Pain Relief, Overactive Bladder, and Acne Treatment.

Our experienced team works closely with each client to address the critical component of product safety assessment. If an Rx-to-OTC switch is in your future, contact us to see how we can help extend the lifecycle of your product.