Regulatory Strategy
- Product development
- Market entry
- Regulatory needs and compliance
- REMS – Risk evaluation and mitigation strategy
Regulatory Submissions & Approvals
- NDA/ANDA/BLA/ MAA
- DMF/CEP/KDMF
- eCTD services
Query Response Management
- Handling queries and requests in compliance with regulatory deadlines
Post Approval Lifecycle Management
- Variations
- Amendments
- Supplements
- Renewals
- Annual Reporting
Import & Registration (CDSCO)
- Registration Certificate
- Import License
Expertise
Our expertise in preparing and submitting regulatory documents to agencies like the FDA, EMA, CDSCO and other national regulatory bodies
