Regulatory Affairs Solution
Streamlined regulatory and quality processes that simplify submissions, accelerate time to market, and ensure compliance.
THE CHALLENGE
A lengthy, complex process
Successfully traversing and managing the complex regulatory landscapes of the pharmaceutical and medical device industries requires a software solution that consolidates regulatory and quality processes. Streamline data sharing with one core solution – from submission management and validation to product information and lifecycle management.
The need to interact, collaborate, and coordinate
It has become increasingly difficult to maintain information concerning the registration status and licensing conditions of all company products on a global basis, while supporting correspondences with regulatory agencies to monitor regulatory history, approval conditions, commitments, and quality aspects of products in any given country.
THE SOLUTION
Complete and Cost-effective RA Process Automation
Dot Compliance’s regulatory information management solution breaks down the traditional siloed approach of communication with regulatory agencies and personnel. Manage all regulatory data and documentation, and registration of products, product variation, and registration renewals in one system. Integration with document control and other system capabilities provides flexible, complete, and cost-effective RA process automation.
PROCESSES COVERED
- Product registration
- Dossier file/Binders (document and binder)
- Registration/submission
- Variation Management (change management)
- Renewal management
- Regulatory correspondence management
- Regulatory commitment tracking
FEATURES & BENEFITS
Simplified & effective registration management
- Solution is compliant with strict industry standards such as 21 CFR Part 11.
- Document control integration Includes validation package and project validation services.
- Automated tracking of the entire registration submission process.
DATASHEET
Dot Compliance Regulatory Affairs Solution
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