Preparing for Success – How to have a positive FDA Inspection
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SMARTDECISIONS
Helping you navigate regulatory complexity
SMARTDECISIONS is a Regulatory Intelligence system for managing officially published Health Authority guidelines, combined with PharmaLex experience and recommended best practices. This tool allows PharmaLex Regulatory experts across the globe to share and access important Regulatory Intelligence information as well as practical submission experience, and finally to improve our Regulatory solutions to our clients.
Features
- Cloud-based system with simple User Interface
- Defines Regulatory Intelligence into specific topics, allowing users to view the latest regulatory intelligence for a selected topic for a selected country
- Structured data approach for intelligence information allows automated processing
- Information is managed by defined data governance processes ensuring it remains current, accurate and trustworthy
- Regulatory Intelligence information is complemented by extensive experience from 10,000s of regulatory submissions worldwide every year
Benefits
- Easy to implement and requires minimal user training
- Reliable, up to date regulatory intelligence is available in a single system in a structured format for optimal usage
- Regulatory Intelligence data is a combination of Health Authority published information, combined with actual experience and recommended best practices
- Supports decision making for key regulatory strategies
