Over-the-Counter(OTC) Drugs Regulatory Services

Over the counter (OTC) drugs are safe-to-use medicines which are available without prescriptions across the globe. Even then, the health authorities (HAs) worldwide maintain a defined pathway for the introduction of OTC medicines into new markets to ensure patient health and safety. As each country has its own regulations, it requires a structured approach and strategy to launch and market OTC across the globe.

Freyr has a strong capability to extend end-to-end OTC Regulatory support to make them reach wider global markets. Freyr’s Regulatory strategy and expertise minimize legislative risks and ensure a speedy launch of your OTC drug in desired geographies. Freyr supports entire life cycle management activities that involve the post-approval support for the maintenance of the marketing authorization licenses. Freyr has a strong foothold in post-approval change remediation, renewals, annual report filling, and response to HA queries.