Regulatory Intelligence and Compliance
Before a drug can be launched it needs to gain approval. With regulations differing across the globe and substantial evidence of safety and efficacy needed, the process of getting a drug approved is not a simple one.
Are you looking to:
- Compare regional requirements across multiple countries?
- Ensure you meet regulatory requirements for submissions?
- Track regulation changes, compare competitive products and prepare for meetings and inspections?
- Understand submission routes and local regulatory practices to ensure you meet the requirements?
- Address needs for specific product categories?
- Access up-to-date and historical regulatory documents and approval information?
- Disseminate regulatory information to internal stakeholders?
- Support and prepare for regulatory inspections?
Solutions
