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 strong capability to extend end-to-end OTC Regulatory support to make them reach wider global markets. Freyr’s Regulatory strategy and expertise minimizes legislative risks and ensures a speedy launch of your OTC drug in desired geographies. Freyr supports for entire life cycle management activities that involves the post approval support for the maintenance of the marketing authorization licenses. Freyr has strong foothold in post approval change remediation, renewals, annual report filling, response to HA queries.
- Gap analysis of technical documents
- Regulatory support for product registration
- Health Agency (HA) liaising and support
- Life cycle management activities support
- Successful submissions for varied class of OTC products
- Access to local affiliate to meet challenges pertaining to language-specific requirements and authority interaction
- In-country or legal representation support with cost-effective model
- Exclusive delivery center in India, United Arab Emirates (UAE), United States of America (USA), Mexico & United Kingdom