CANADA
Amarant provides comprehensive regulatory affairs solutions for a spectrum of drug products. We ensure continuous compliance with Canadian regulatory standards and GMP regulations. These services seamlessly integrate with our other end-to-end solutions. Our team comprises globally recognized experts in the field.
Services We Offer
- Regulatory intelligence & regulatory strategy
- Expert reports in line with current regulations
- DMF review
- Preparation, review, submission & registration of dossiers
- Gap analysis
- Evaluation & submission of post-approval changes
- Query responses
- Lifecycle Management – annual reports
- Labeling & Artwork Pack Management
- Registration pathways and license management services
- Quality Management Systems (QMS)
- Regulatory road map for market access